Latest news with #KalVistaPharmaceuticals
Medscape
3 days ago
- Health
- Medscape
EMA Backs First Oral Treatment for Hereditary Angioedema
At its July 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for sebetralstat (Ekterly, KalVista Pharmaceuticals) for symptomatic treatment of acute attacks of hereditary angioedema in adults and adolescents aged 12 years or older. Hereditary angioedema is a rare, chronic, and potentially life-threatening genetic condition caused by deficiency or dysfunction of C1 esterase inhibitor, leading to excessive bradykinin and unpredictable swelling episodes in the face, abdomen, limbs, and airways. Sebetralstat is a selective oral plasma kallikrein inhibitor designed for administration at the earliest sign of an angioedema attack. It blocks the overactivation of the kallikrein-kinin system, preventing the formation of bradykinin, a key mediator of swelling in the condition. If approved by the European Commission, the drug will be the first oral on-demand treatment for hereditary angioedema in the European Union. The CHMP opinion was based on efficacy and safety data from a phase 3 KONFIDENT trial, which randomized 136 patients with hereditary angioedema. Findings showed that sebetralstat led to significantly faster symptom relief and reduction in attack severity and attack resolution than placebo. It was also well-tolerated with a safety profile similar to placebo. Ekterly will be available in 300-mg film-coated tablets. The most common side effect reported is headache. One of the key advantages of the drug is its oral route of administration, offering patients a more convenient alternative to injectable therapies. This may significantly reduce the time between an angioedema attack onset and treatment administration. Ekterly was granted orphan medicine status during its development due to its targeted use in a rare, life-threatening condition. The EMA noted that the drug would have been unlikely to be developed without such incentives and is now reviewing the available data to determine whether the orphan designation should be maintained.
Business Wire
6 days ago
- Health
- Business Wire
KalVista Pharmaceuticals Receives Positive CHMP Opinion for Sebetralstat for the Treatment of Hereditary Angioedema Attacks
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for sebetralstat, a novel oral plasma kallikrein inhibitor, for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The European Commission (EC) final decision is expected by early October. 'This positive CHMP opinion is an important step forward for people living with HAE in Europe, where there remains a high need for effective, easy-to-administer on-demand treatments,' said Ben Palleiko, CEO of KalVista. 'Coming just weeks after regulatory approvals in the US and UK, this milestone highlights the potential of sebetralstat to transform how HAE is managed globally. Sebetralstat is expected to become the first and only oral on-demand treatment for HAE available in Europe, bringing forward a new treatment approach that enables adherence to guidelines and empowers people to treat attacks quickly, wherever they occur.' The CHMP based its opinion on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical trial ever conducted in HAE. Data from KONFIDENT was published in the New England Journal of Medicine in May 2024, showing that sebetralstat achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo.1 The trial randomized 136 HAE patients from 66 clinical sites across 20 countries. 'Access to on-demand treatments that offer easy self-administration and rapid symptom relief is critical for patients living with HAE,' said Emel Aygören-Pürsün, M.D., Assistant Professor, Internal Medicine and Hemostaseology, Department for Children and Adolescents, University Hospital Frankfurt. 'Until now, on-demand therapies for HAE attacks required parenteral administration via injections. The positive CHMP opinion for sebetralstat is an essential move toward a novel, long-awaited oral on-demand option that could help patients treat attacks early and independently, as advocated by guidelines, with the goal of improving outcomes and normalizing lives.' Sebetralstat is approved in the United States and United Kingdom under the brand name EKTERLY® for the treatment of HAE attacks in people 12 years of age and older. It is currently under review with regulatory authorities in Japan as well as multiple other territories. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity. About Sebetralstat Sebetralstat is a novel plasma kallikrein inhibitor approved in the United States and United Kingdom for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. It is the first and only oral on-demand treatment for HAE. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. U.S. INDICATION AND IMPORTANT SAFETY INFORMATION What is EKTERLY® (sebetralstat)? EKTERLY is a prescription medicine used to treat sudden (acute) attacks of hereditary angioedema (HAE) in adults and children aged 12 years of age and older. It is not known if EKTERLY is safe and effective in children under 12 years of age. IMPORTANT SAFETY INFORMATION Before taking EKTERLY, tell your healthcare provider about all of your medical conditions, including if you: Are pregnant or planning to become pregnant. It is not known if EKTERLY can harm your unborn baby. Are breastfeeding or plan to breastfeed. It is not known if EKTERLY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking EKTERLY. Have liver problems. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking EKTERLY with certain other medicines can cause side effects or affect how well EKTERLY or the other medicines work. Especially tell your healthcare provider if you take any of the following, as their use with EKTERLY is not recommended: itraconazole, phenytoin, efavirenz. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. What are the possible side effects of EKTERLY? The most common side effects of EKTERLY include headache. For more information, ask your healthcare provider or pharmacist. Talk to your doctor for medical advice about side effects. You are encouraged to report side effects related to KalVista products by calling 1-855-258-4782. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit or call 1-800-FDA-1088. Please click here for full Prescribing Information, including Patient Information. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, including approval by the EC, our expectations about the timing of the EC's final decision, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. _______________________ Expand 1Riedl MA, et al. Oral sebetralstat for on-demand treatment of hereditary angioedema attacks. N Engl J Med. 2024;391(1):32–43. Expand
Yahoo
14-07-2025
- Business
- Yahoo
US High Growth Tech Stocks Leading The Market
The United States market remained flat over the last week, but it has risen 13% over the past 12 months with earnings forecasted to grow by 15% annually. In this context, identifying high growth tech stocks that align with these positive earnings projections can be key to capitalizing on potential future opportunities in the sector. Name Revenue Growth Earnings Growth Growth Rating Super Micro Computer 24.71% 39.09% ★★★★★★ Circle Internet Group 30.78% 60.64% ★★★★★★ Ardelyx 21.16% 61.58% ★★★★★★ Mereo BioPharma Group 50.84% 58.22% ★★★★★★ TG Therapeutics 26.46% 38.75% ★★★★★★ AVITA Medical 27.42% 61.04% ★★★★★★ Alnylam Pharmaceuticals 23.86% 59.49% ★★★★★★ Alkami Technology 20.53% 76.67% ★★★★★★ Ascendis Pharma 35.07% 59.83% ★★★★★★ Lumentum Holdings 23.14% 103.97% ★★★★★★ Click here to see the full list of 228 stocks from our US High Growth Tech and AI Stocks screener. We're going to check out a few of the best picks from our screener tool. Simply Wall St Growth Rating: ★★★★★☆ Overview: KalVista Pharmaceuticals, Inc. is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of drug therapies for diseases with unmet needs, with a market cap of $748.72 million. Operations: KalVista Pharmaceuticals specializes in developing drug therapies, particularly inhibitors, targeting diseases with unmet needs. The company operates as a clinical stage entity without reported revenue segments, focusing on advancing its pipeline through discovery and development phases. KalVista Pharmaceuticals, recently approved by the FDA for its novel treatment EKTERLY®, is poised to revolutionize care for hereditary angioedema (HAE) with the first oral on-demand option. This approval follows a robust KONFIDENT trial, which demonstrated EKTERLY®'s efficacy in significantly reducing symptom severity and attack resolution times compared to placebo. With an annual revenue growth forecast at 49.7% and earnings expected to surge by 54.67%, KalVista's strategic focus on R&D has positioned it well within the high-growth biotech sector, despite current unprofitability. The company's recent distribution agreement with Pendopharm® marks a significant step towards expanding its market reach in Canada, enhancing its growth trajectory amidst a competitive landscape. Delve into the full analysis health report here for a deeper understanding of KalVista Pharmaceuticals. Gain insights into KalVista Pharmaceuticals' past trends and performance with our Past report. Simply Wall St Growth Rating: ★★★★★☆ Overview: Hut 8 Corp. is a vertically integrated operator of energy infrastructure and Bitcoin mining in North America with a market capitalization of $2.44 billion. Operations: Hut 8 Corp. generates revenue through its power segment, contributing $51.04 million, and digital infrastructure, adding $20.99 million. The company is involved in energy infrastructure and Bitcoin mining operations across North America. Amidst a challenging landscape, Hut 8's Vega facility marks a significant stride in Bitcoin mining technology. With an innovative liquid cooling system, the facility optimizes thermal efficiency and operational reliability, supporting compute densities up to 180 kilowatts per rack—a notable advancement over traditional air-cooled systems. Despite recent drops from various Russell indexes and a substantial net loss reported in Q1 2025, Hut 8's amended credit agreement with Coinbase suggests strategic financial maneuvering to bolster its growth trajectory. This move could potentially stabilize the company amidst volatile market conditions and pave the way for leveraging emerging high-performance computing workloads. Take a closer look at Hut 8's potential here in our health report. Gain insights into Hut 8's historical performance by reviewing our past performance report. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Altice USA, Inc. operates as a provider of broadband communications and video services under the Optimum brand across the United States, Canada, Puerto Rico, and the Virgin Islands with a market cap of approximately $1.04 billion. Operations: Altice USA, operating under the Optimum brand, generates revenue primarily from its cable segment, which amounts to approximately $8.86 billion. The company focuses on delivering broadband communications and video services across multiple regions. Altice USA's recent inclusion in multiple Russell indexes underscores its potential in the tech sector, despite a forecasted annual revenue decline of 2%. This juxtaposition highlights the company's strategic positioning and investor interest. With earnings expected to grow by 66.76% annually, Altice is navigating its financial challenges, evidenced by a significant net loss of $75.68 million in Q1 2025. These developments suggest a complex but possibly rewarding future as it aims for profitability amidst operational adjustments and market recognition. Click here and access our complete health analysis report to understand the dynamics of Altice USA. Evaluate Altice USA's historical performance by accessing our past performance report. Discover the full array of 228 US High Growth Tech and AI Stocks right here. Invested in any of these stocks? Simplify your portfolio management with Simply Wall St and stay ahead with our alerts for any critical updates on your stocks. Streamline your investment strategy with Simply Wall St's app for free and benefit from extensive research on stocks across all corners of the world. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include KALV HUT and ATUS. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-07-2025
- Business
- Yahoo
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year 2025 Financial Results
– Received FDA approval of EKTERLY® (sebetralstat)—the first and only oral on-demand treatment for hereditary angioedema; U.S. launch underway – – Six additional global regulatory submissions under review – – Entered licensing agreements for sebetralstat commercialization in Japan and Canada – – $220.6M in cash, providing runway into 2027 – CAMBRIDGE, Mass. & SALISBURY, England, July 10, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2025. "The FDA approval of EKTERLY represents a major milestone—not only as the first commercial product for KalVista, but more importantly, as the first and only oral on-demand therapy for people living with HAE," said Ben Palleiko, CEO of KalVista Pharmaceuticals. "EKTERLY delivers a long-awaited treatment that is safe, effective, and easy to administer. Our commercial team is actively engaging in the field, leveraging their expertise to educate and activate patients and physicians to enable timely access, drive awareness, and support informed treatment decisions around this important new therapy. With commercial partners now in place in Canada and Japan, and six global regulatory submissions under review, we believe EKTERLY is poised to become the foundational therapy for HAE management worldwide." Recent Business Highlights EKTERLY® (sebetralstat) On July 7, 2025, KalVista announced FDA approval of EKTERLY (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. KalVista further strengthened the robust body of clinical evidence supporting the efficacy and safety of EKTERLY (sebetralstat) for the treatment of HAE. The Company presented new data at the European Academy of Allergy and Clinical Immunology Congress 2025 (EAACI), the 14th C1-inhibitor Deficiency & Angioedema (C1-INH) Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida. Key highlights from these medical congresses are outlined below: EAACI: Data showed the efficacy of EKTERLY (sebetralstat) for the on-demand treatment of HAE attacks among patients receiving long-term prophylaxis (LTP). Real world data highlighted significant challenges with LTP adherence, and ongoing reliance on on-demand medications. In KONFIDENT-S, EKTERLY (sebetralstat) delivered rapid, consistent relief for attacks, regardless of LTP mechanism of action with a median time to beginning of symptom relief of 1.3 hours. C1-INH: Analysis from nearly 1,600 attacks in KONFIDENT-S showed a median time to end of attack progression of 19.8 minutes. These results aligned closely with KONFIDENT, reinforcing the rapid effect of EKTERLY (sebetralstat) after absorption. Interim data from KONFIDENT-S highlighted the role of EKTERLY (sebetralstat) in treating mucosal attacks with a median time to beginning of symptom relief of 1.3 hours for both abdominal and laryngeal attacks. EAC: In KONFIDENT-S, EKTERLY (sebetralstat) was used to treat 76 attacks that had progressed to severe or very severe after a median of 2.16 hours from attack onset, demonstrating its utility in more advanced stages of HAE attacks. The median time to beginning of symptom relief for these attacks was 1.36 hours, with reduction in attack severity and substantial reduction of symptom burden in a median of 1.77 hours and 9.15 hours, respectively. Organizational In April, KalVista entered into an exclusive agreement with Kaken Pharmaceutical, Co., Ltd. to commercialize sebetralstat in Japan. Under the terms of the deal, in June 2025 KalVista received an upfront payment of $11 million, and an additional $11 million will be paid upon achieving a regulatory milestone anticipated in early 2026. This agreement also includes potential commercial milestone payments of up to $2 million and royalties based on the Japan National Health Insurance (NHI) price, with royalties expected to be in the mid-twenties as a percentage of sales. In June, KalVista granted Pendopharm, a division of Pharmascience Inc., the exclusive rights to manage the regulatory approval process and commercialization of sebetralstat in Canada. Financial Results for Fiscal Year Ended April 30, 2025: Research and development expenses were $71.7 million and $86.2 million for the fiscal years ended April 30, 2025, and 2024, respectively. The decrease in R&D was primarily attributable to reduced clinical trial expenses, preclinical activities and recognizing expense associated with EKTERLY (sebetralstat) pre-commercial awareness within General & Administrative. General and administrative expenses were $116.3 million and $54.3 million for the fiscal years ended April 30, 2025, and 2024, respectively. The increase in G&A expenses was primarily due to pre-commercial planning expenses related to EKTERLY (sebetralstat). Cash, cash equivalents and marketable securities were $220.6 million on April 30, 2025, compared to $210.4 million on April 30, 2024. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE , and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. KALVISTA PHARMACEUTICALS, INC. Consolidated Balance Sheets April 30, 2025 and 2024 (in thousands except share and per share amounts) (Unaudited) 2025 2024 Cash, cash equivalents & Marketable securities $ 220,617 $ 210,401 Other current assets 21,073 15,289 Total current assets 241,690 225,690 Other assets 9,080 9,714 Total assets $ 250,770 $ 235,404 Current liabilities $ 45,167 $ 22,807 Long-term liabilities 110,212 6,015 Total Liabilities 155,379 28,822 Stockholders' equity 95,391 206,582 Total liabilities and stockholders' equity $ 250,770 $ 235,404 KALVISTA PHARMACEUTICALS, INC. Consolidated Statements of Operations and Comprehensive Loss Years Ended April 30, 2025 and 2024 (in thousands, except share and per share amounts) (Unaudited) 2025 2024 Research and development $ 71,709 $ 86,167 General and administrative 116,286 54,278 Total operating expenses 187,995 140,445 Operating loss (187,995 ) (140,445 ) Other income: Interest income 6,435 3,896 Interest (expense) (5,785 ) — Foreign currency exchange gain (loss) 2,481 138 Other income (expenses), net 4,812 9,767 Total other income 7,943 13,801 Loss before income taxes (180,052 ) (126,644 ) Income tax (benefit) expense 3,392 — Net loss $ (183,444 ) $ (126,644 ) Net loss per share, basic and diluted $ (3.69 ) $ (3.44 ) Weighted average common shares outstanding, basic and diluted 49,652,878 36,786,575 View source version on Contacts Investors: Ryan BakerHead, Investor Relations(617) Media: Molly CameronDirector, Corporate Communications(857) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
WebMD
08-07-2025
- Health
- WebMD
FDA Approves First Oral Treatment for Rare Swelling Disorder
July 8, 2025 – The FDA has approved the first-ever pill for a rare genetic swelling disorder. The drug, known as sebetralstat but sold as Ekterly, is for adults and children age 12 years or older with hereditary angioedema (HAE), which affects about 1 in 50,000 people and causes sudden and painful swelling that can sometimes be life-threatening. These easy-to-take pills help stop an attack whenever it happens, offering an advantage over other treatments that need to be injected either into the veins or under the skin. HAE happens when a person has a faulty gene that causes their body to make too little of a protein called C1 inhibitor, or the protein doesn't work well. This protein usually helps control swelling and inflammation in the body. This genetic defect can cause swelling in the face, throat, abdomen, or limbs, which can sometimes be serious. Those with the condition who have swelling in the abdomen can have stomach pain, vomiting, or diarrhea. Swelling in the throat or face can make it hard to breathe. Even with regular treatment, many people with HAE still have sudden attacks and always need fast-acting medicine available to them. "As the first orally administered on-demand therapy for HAE attacks, Ekterly provides patients and physicians with an important and welcome advance in HAE treatment options," Anthony J. Castaldo, chief executive officer of the US Hereditary Angioedema Association, said in a statement. Ekterly was approved after a study involving 136 people with HAE across 20 countries showed that it could quickly relieve symptoms and help end attacks sooner, compared to a placebo, regardless of how severe the attack was. In a follow-up study, many people were able to take the pill within 10 minutes of an attack, and symptoms began to improve in about 1.3 hours, according to a news release from KalVista Pharmaceuticals, the drug's maker. Ekterly works by blocking an enzyme called plasma kallikrein, which causes swelling. In people with HAE, this enzyme is too active because the C1 inhibitor protein does not work properly. By blocking this enzyme, Ekterly helps stop sudden swelling and pain from happening. The pill lets people treat attacks early, giving them more control and helping doctors lower the impact of the disease. According to KalVista, the medicine will be available right away. Headaches are the only reported side effect of the new treatment. It's not known if the medicine is safe during pregnancy or breastfeeding, so patients should tell their doctor if they are pregnant, planning to become pregnant, or breastfeeding. Patients should also tell their doctor if they have liver problems or are taking other medicines, especially for fungal or viral infections, or epilepsy.
