Latest news with #Lenacapavir
Yahoo
22 minutes ago
- Business
- Yahoo
Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention
– If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV PrEP Option in the European Union – – Positive Opinion Also Received for EMA's EU-M4all Procedure, Designed to Facilitate Availability in Low- and Lower-Middle-Income Countries – FOSTER CITY, Calif., July 25, 2025--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company's injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The final European Commission (EC) decision is expected later this year, and, if approved, lenacapavir will be marketed in the European Union (EU) under the trade name Yeytuo®. The marketing authorization application (MAA) recommendation will now be reviewed by the EC as it evaluates lenacapavir as a potential new preventative strategy against HIV in all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Additionally, if approved, lenacapavir will be granted one additional year of market exclusivity in the EU as a result of the new indication. The CHMP also adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries (LLMICs). "This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world," said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. "Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care." Despite ongoing advances in HIV prevention, persistent social and economic factors including stigma and discrimination continue to cause disparities in PrEP use. In 2023, a total of 24,731 new HIV diagnoses were reported across 30 EU/European Economic Area countries—an increase of 11.8% compared with 2022. "These positive opinions from the CHMP are an important step toward a new HIV prevention option that could help meet the diverse needs of people across Europe and aim at helping end new HIV infections by the EU target of 2030," said Jean-Michel Molina, MD, PhD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals. "The opinions reflect the strength of the clinical evidence and the potential of long-acting innovations like lenacapavir to address real-world barriers to the use of PrEP. Expanding the range of PrEP options, in Europe and in countries around the world, is essential to making HIV prevention more accessible for people who need it most." The positive opinions were supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial (NCT04925752), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, lenacapavir demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Continued Global Regulatory Filings for Lenacapavir for HIV Prevention, Milestone Partnerships and Global Guidance Gilead is executing a global access strategy informed by health advocates and organizations that prioritizes speed and enables the most efficient paths for regulatory review, approval of and access to twice-yearly lenacapavir for PrEP. More information about Gilead's recently announced strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as updates on Gilead's access strategies in countries and regions around the world: See Gilead press release More information about the WHO's recently announced guidelines for the use of lenacapavir for PrEP: See Gilead company statement Lenacapavir for PrEP is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. About the PURPOSE Program Gilead's landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents (≥35kg) who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 "Breakthrough of the Year." U.S. Indication for Yeztugo® Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available at Truvada, Truvada for PrEP, Yeztugo, Yeytuo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on Contacts Ashleigh Koss, Mediapublic_affairs@ Jacquie Ross, Investorsinvestor_relations@ 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
Reuters
24 minutes ago
- Health
- Reuters
EU regulator backs Gilead's twice-yearly injection for HIV prevention
July 25 (Reuters) - The European Union's drugs regulator has recommended approval of Gilead Sciences' (GILD.O), opens new tab lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents, the drugmaker said on Friday. The backing could make it the EU's first twice-yearly HIV prevention option to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents. Lenacapavir offers a long-acting alternative to daily oral pills and other shorter-acting options, aiding critical response to the disease especially among those who struggle with daily adherence, stigma, or access to healthcare. The decision comes more than a month after the treatment received regulatory approval in the U.S., where it is branded as Yeztugo. The World Health Organization recommended the treatment earlier this month as a tool to prevent HIV infection. Any recommendation by the European Medicines Agency's human medicines committee has to be formally approved by the European Commission, which usually follows the regulator's decision. The European Commission's decision on the drug is expected later this year, the company said. If approved,lenacapavir would be granted one additional year of market exclusivity in the EU, and it would be branded as Yeytuo, Gilead said. Lenacapavir, part of a class of drugs known as capsid inhibitors, proved nearly 100% effective at preventing HIV in large trials last year.
The Star
2 days ago
- Health
- The Star
Lenacapavir: A game changer for HIV prevention in South Africa
"This is a game changer for South Africa," said Health Minister Aaron Motsoaledi as T he Global Fund to Fight AIDS, Tuberculosis and Malaria on Wednesday secured access to breakthrough HIV prevention for low and middle income countries. "Lenacapavir offers young women, and everyone at risk, a discreet, long-acting option to stay HIV-free. " For far too long, women and girls in our country have carried the greatest burden of this epidemic. "But scientific breakthroughs must be backed by political will, community leadership, and sustained investment. We are determined to ensure no one is left behind.' The deal signed between with US pharmaceutical giant Gilead and the Global Fund will mean lower-income countries will gain access to a the HIV prevention drug at the same time as in high-income countries. There was particular urgency in countries like South Africa, where adolescent girls and young women are disproportionately affected by HIV. The Global Fund said it hoped the agreement with Gilead would make it possible to reach two million people with the drug, which was approved by the US Food and Drug Administration last month. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections.
India.com
17-07-2025
- Health
- India.com
A New HIV Shield: One Shot Every Six Months – Could This Be The Turning Point The World's Been Waiting For?
New Delhi: A new drug that could change the way the world prevents HIV has just received the green signal from the World Health Organization (WHO). Its name is Lenacapavir. And what makes it different? You only need it twice a year. The announcement came from Kigali, Rwanda, where global health experts gathered for the 13th International AIDS Society Conference on July 14. WHO shared new global guidelines to strengthen HIV prevention, and with it, officially recommended Lenacapavir as a key tool – especially for those who face high risk every day. They include sex workers, healthcare workers and people in close contact with HIV-positive individuals. This long-acting drug is not entirely new. The United States approved it earlier. Back in 2022, it was already being used to treat HIV-affected patients. Now, WHO's decision brings it into focus as a prevention method, specifically for pre-exposure prophylaxis (PrEP). WHO Director-General Dr. Tedros Adhanom Ghebreyesus said, 'We still do not have a vaccine for HIV. But this drug, taken only twice a year, is the best new option we have got.' Globally, the HIV burden remains heavy. In 2024 alone, 1.3 million people were infected. Lenacapavir is being hailed as a potential game-changer for global HIV prevention, particularly among communities like sex workers, transgender individuals, people in correctional facilities, men who have sex with men and those who inject drugs, all of whom have been disproportionately affected. Funding for HIV prevention is drying up in many regions. That is why this drug, which works longer and requires fewer doses, feels like a breakthrough. Lenacapavir is a product of U.S. biopharma giant Gilead Sciences. It belongs to a class of medicines called capsid inhibitors, which disrupt multiple steps in the HIV life cycle and help block the virus from replicating. What sets it apart is its long-acting nature. Just two injections a year are enough to offer sustained protection, a significant improvement over daily pills or monthly regimens that are harder to maintain. Compared to daily pills or monthly shots, Lenacapavir offers a simple solution – two injections a year. For those facing daily exposure to risk, this could be the protection they have been waiting for. The need for such interventions has never been more urgent. Over 1.3 million people contracted HIV in 2024 alone, according to WHO data. A large share of these infections occurred in low- and middle-income countries, where preventive care is either unavailable or underfunded. As funding for HIV prevention declines globally, a low-maintenance, highly effective drug like Lenacapavir could help reverse troubling trends. Public health experts say its biannual dosage makes adherence easier, especially for people with limited access to clinics or stigmatised by their communities. While the drug is yet to be rolled out widely, WHO has urged governments and NGOs to accelerate access through partnerships with local health systems. With global focus now shifting toward long-term, low-cost solutions, Lenacapavir offers a ray of hope in a decades-long battle against HIV.
Yahoo
15-07-2025
- Business
- Yahoo
Bernstein Maintains Buy Rating on Gilead Sciences (GILD) Stock
Gilead Sciences, Inc. (NASDAQ:GILD) is one of the Best Large Cap Value Stocks to Invest In. Analyst Courtney Breen of Bernstein maintained a 'Buy' rating on the company's stock, retaining a price objective of $120.00. The analyst's rating is backed by a combination of factors associated with the promising prospects of the new drug, Yeztugo. The drug, which is also known as Lenacapavir, was recently approved by the FDA for use as a monotherapy in preventing HIV, which can significantly drive Gilead Sciences, Inc. (NASDAQ:GILD)'s growth, added the firm's analyst. A physician and a patient having a discussion in a hospital about biopharmaceutical medicines. Furthermore, the innovation in Yeztugo's dosing paradigm is expected to enhance patient adherence as well as expand the PrEP market. Despite the concerns related to the drug's pricing, the analyst believes that the perceived financial burden might be mitigated by the insurance coverage. The analyst has also highlighted Gilead Sciences, Inc. (NASDAQ:GILD)'s strategic efforts to address logistical challenges. Overall, such factors, together with the drug's clinical differentiation and market receptivity, support the analyst's favourable outlook for the company's stock. Notably, the company has announced a strategic partnership agreement with the Global Fund to fight AIDS, Tuberculosis, and Malaria to supply lenacapavir, Gilead Sciences, Inc. (NASDAQ:GILD)'s twice-yearly injectable HIV-1 capsid inhibitor, for preventing HIV as pre-exposure prophylaxis (PrEP). Impax Asset Management, an investment management company, released its Q1 2025 investor letter. Here is what the fund said: 'Gilead Sciences, Inc. (NASDAQ:GILD) (Health Care) the company is owned due to its role in solving evolving heath care challenges through the development of new medical treatments for conditions as chronic diseases are on the rise. The company also has one of the highest systematic ESG scores in the portfolio. Gilead reported better-than-expected quarterly results, largely driven by strong revenue from its HIV franchise. The company also provided an optimistic earnings guidance for the next fiscal year, helping provide defensiveness amid a flurry of volatility.' While we acknowledge the potential of GILD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 13 Cheap AI Stocks to Buy According to Analysts and 11 Unstoppable Growth Stocks to Invest in Now Disclosure: None. This article is originally published at Insider Monkey. 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
