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Yahoo
25 minutes ago
- Yahoo
TRYNGOLZA® (olezarsen) recommended for approval in the EU by CHMP for familial chylomicronemia syndrome (FCS)
– Recommendation based on Phase 3 Balance results, which showed a significant reduction of triglycerides and substantial reduction of acute pancreatitis events with TRYNGOLZA – – European Commission decision expected by Q4 2025 – CARLSBAD, Calif., July 25, 2025--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Sobi® today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion of TRYNGOLZA® (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). The positive opinion is now referred to the European Commission (EC) for an approval decision, which is expected by Q4 2025. "Building on the strong early launch of TRYNGOLZA in the U.S., the positive CHMP opinion advances our commitment to expand access to TRYNGOLZA globally," said Brett P. Monia, Ph.D., chief executive officer, Ionis. "TRYNGOLZA has demonstrated significant reductions in triglycerides and substantial reductions in acute pancreatitis events with favorable safety and tolerability. With this robust clinical profile, combined with Sobi's deep commercial market expertise in FCS, TRYNGOLZA has the potential to make a meaningful difference for people living with FCS in the EU." The CHMP opinion is based on positive data from the Phase 3 Balance study, in which TRYNGOLZA demonstrated a statistically significant reduction in triglyceride levels at six months that was sustained through 12 months. Additionally, TRYNGOLZA demonstrated a substantial and clinically meaningful reduction in acute pancreatitis events over 12 months. TRYNGOLZA showed a favorable safety and tolerability profile. Study results were published in The New England Journal of Medicine (NEJM). FCS is a rare and genetic form of severe hypertriglyceridemia (sHTG) that prevents the body from breaking down fats and severely impairs the ability to remove triglycerides from the bloodstream. People with FCS often have triglyceride levels of more than 880 mg/dL (10 mmol/L), compared to normal levels of <150 mg/dL (1.7 mmol/L), and are at high risk of developing acute pancreatitis, which can be life-threatening. In the EU, FCS is estimated to impact up to 13 people per million. Sobi has exclusive rights to commercialize TRYNGOLZA in countries outside the U.S., Canada and China. As Ionis' European commercial partner for Waylivra (volanesorsen), the only medicine currently approved for FCS in the EU, Sobi will leverage existing market expertise and distribution channels to enable an effective TRYNGOLZA launch in FCS, if approved. "The approval recommendation brings us one step closer toward delivering TRYNGOLZA to people living with FCS in the EU and is a testament to our long-standing support for the FCS community," said Lydia Abad-Franch, M.D., MBA, head of research, development and medical affairs and chief medical officer, Sobi. "Patients with FCS suffer from complications such as acute pancreatitis. These are very severe events, often requiring intensive care and sometimes causing multiorgan failure as well as increasing morbidity and mortality. We believe TRYNGOLZA has the potential to be an important treatment for people living with this rare and serious disease, and we look forward to the final decision from the EC later this year." TRYNGOLZA was approved in the United States in December 2024 and granted orphan designation in the EU. Olezarsen is also being evaluated for sHTG, a serious condition defined by dangerously high triglycerides (≥500 mg/dL), and data from the Phase 3 CORE and CORE2 studies are expected in Q3 2025. About the Balance Study Balance is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of olezarsen in patients with FCS at six and 12 months. The primary endpoint was the percent change from baseline in fasting triglyceride levels at six months compared to placebo. Secondary endpoints included percent changes in triglyceride levels at 12 months, percent changes in other lipid parameters and adjudicated acute pancreatitis event rates over the treatment period. Following treatment and the end-of-trial assessments, patients were eligible to enter an open-label extension study to continue receiving olezarsen once every four weeks. About Familial Chylomicronemia Syndrome (FCS) FCS is a rare, genetic disease characterized by extremely elevated triglyceride levels. It is caused by impaired function of the enzyme lipoprotein lipase (LPL). Because of limited LPL production or function, people with FCS cannot effectively break down chylomicrons, lipoprotein particles that are 90% triglycerides. People living with FCS are at high risk of acute pancreatitis in addition to other chronic health issues such as fatigue and severe, recurrent abdominal pain. People living with FCS are sometimes unable to work, adding to the burden of disease. About TRYNGOLZA® (olezarsen) TRYNGOLZA® is an RNA-targeted medicine designed to lower the body's production of apoC-III, a protein produced in the liver that is a key regulator of triglyceride metabolism. TRYNGOLZA® (olezarsen) is approved in the United States as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). For more information about TRYNGOLZA, visit TRYNGOLZA is not yet approved for any indication in Europe. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to TRYNGOLZA or any of the excipients in TRYNGOLZA. Hypersensitivity reactions requiring medical treatment have occurred. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills and myalgias) have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. ADVERSE REACTIONS The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count and arthralgia. Please see full Prescribing Information for TRYNGOLZA. About Ionis Pharmaceuticals, Inc. For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis currently has marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit and follow us on X (Twitter), LinkedIn and Instagram. Ionis Forward-looking Statements This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of our commercial medicines, olezarsen, additional medicines in development and technologies. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2024, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company. In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our" and "us" all refer to Ionis Pharmaceuticals and its subsidiaries. Ionis Pharmaceuticals® and TRYNGOLZA® are trademarks of Ionis Pharmaceuticals, Inc. View source version on Contacts Ionis Investor Contact: D. Wade Walke, 760-603-2331Ionis Media Contact: Hayley Soffermedia@ 760-603-4679 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
Bloomberg
28 minutes ago
- Bloomberg
Supertanker Hauling Saudi Diesel Heads to Fuel-Starved Europe
A supertanker carrying a cargo of diesel from the Middle East is en route to the fuel-starved European market, reflecting supply tightness in the region. The VLCC Nissos Keros loaded about 2 million barrels of ultra-low sulfur diesel from Saudi Arabia's Jubail terminal and is currently signaling France where it's due to arrive Aug. 30, according to Kpler and ship-tracking data compiled by Bloomberg.
CNBC
28 minutes ago
- CNBC
What Europe's response to a no-deal with Trump could look like
Brussels is preparing for a no-deal scenario as uncertainty persists about if and when a trade agreement between the European Union and U.S. will materialize. Lawmakers on Thursday signed off on a major package of counter-tariffs which would target a wide range of goods and discussions are reportedly ongoing about deploying the EU's so-called "trade bazooka." Measures could kick in soon as there are just a few days left before Aug. 1, after which EU imports to the U.S. are set to be slapped with 30% tariffs and the EU is expected to respond promptly. Talks of a potential deal have however also been heating up this week, with sources telling CNBC that the current base-case scenario for a deal includes a 15% tariff on EU imports to the U.S. Any possible exemptions are still being worked out, they noted. But crucially, much depends on U.S. President Donald Trump, who is known for last minute changes of heart and quick decision making. There are therefore no guarantees about what a potential deal could look like. This week the European Commission combined two packages of proposed duties into one list, which totals tariffs on 93 billion euros ($109 billion) of a wide range of goods from food and drink items to clothing and machinery. A source told CNBC earlier this week that tariffs could be as high as 30%, mirroring those from the U.S. EU member states reportedly on Thursday voted to approve the combined list. The measures are set to come into effect just days after the U.S.' Aug. 1 deadline. Carsten Brzeski, global head of macro at ING, told CNBC on Friday that he expects tariff-level retaliation from the EU in the absence of a deal. "In a non-deal scenario without another delay of US tariffs, I see the EU going for a tit-for-tat approach, ie imposing 30% tariffs on selected US goods, not yet all goods, like the well-known motorcycles, cars, clothing and alcohol," he said in emailed comments. "Given that European countries are not fully aligned on how to react, I cannot see the EU going full in but rather trying to find a balance between showing that it reacts but without going beyond the US measures," Brzeski added. Another widely discussed option is the EU's so-called anti-coercion instrument, which has been referred to as a "trade bazooka." The measure is designed to be a deterrent, with the European Commission saying it would "be most successful if there is no need to use it." But if a third country does engage in coercion, "the instrument allows the Union to formally identify instances of economic coercion and to respond." The bloc views economic coercion as interference from non-EU countries in the region's policies by threatening or imposing measures that impact trade and investment. While the European Commission notes that dialogue and engagement would be part of their response to such coercion, the ACI for example, also allows for import and export curbs and restrictions on accessing the EU's market. The EU may be able to impose export restrictions regardless of whether it deploys its anti-coercion instrument, said ING's Brzeski. Alberto Rizzi, policy fellow at the European Council on Foreign Relations, told CNBC on Friday that even though the ACI is considered the 'nuclear option,' "in reality there is room for flexibility in its application, as long as the retaliatory measures remain proportionate to the harm of the coercion." Rizzi suggested that despite the mood across the EU shifting to become more confrontational and supportive of "swift and substantial" retaliation in a no-deal scenario, it is uncertain when the ACI could be activated. "Retaliation is seen as a negotiating tool by the EU, so the ACI will probably be activated only in a second phase if there is no response by the US after the tariff packages enters into force — the EU would want to keep it as leverage rather than using it immediately," he said.
