New Cholesterol Treatments Authorized in Europe
Patients with high cholesterol now have two new medication options to help manage their LDL-C levels.
Updated on Sept. 21, 2026 in Heart Disease
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The European Commission has granted marketing authorization for the cholesterol-lowering drugs Ubeslo and Evlarco. These treatments are intended for patients with primary hypercholesterolaemia who require additional help managing their levels.
Why it matters
These drugs provide new alternatives for individuals with high LDL-C who have found existing therapies either insufficiently effective or difficult to tolerate. The approval aims to expand the current options for managing cardiovascular risk factors.
In Phase 3 trials including BROADWAY, BROOKLYN, and TANDEM, obicetrapib monotherapy achieved LDL-C reductions of up to 40% compared to placebo. When combined with ezetimibe, the medication demonstrated reductions of approximately 50% against placebo.
The players
European Commission
The executive branch of the European Union responsible for granting marketing authorizations for pharmaceutical products.
Menarini Group
An international pharmaceutical company based in Italy that holds exclusive commercialization rights for obicetrapib in Europe.
NewAmsterdam Pharma
A clinical-stage biopharmaceutical company focused on developing therapies for cardiovascular disease.
The details
Ubeslo consists of a 10 mg dose of obicetrapib, while Evlarco combines 10 mg of obicetrapib with 10 mg of ezetimibe. These treatments work to lower low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolaemia, including those with heterozygous familial and non-familial or mixed dyslipidaemia.
Timeline
March 2022: The PREVAIL cardiovascular outcomes trial commenced.
April 2024: Enrollment for the PREVAIL trial was completed with over 9,500 patients.
September 21, 2026: The European Commission granted marketing authorization for Ubeslo and Evlarco.
Health Landscape
This regulatory approval adds a new class of treatment options to the existing landscape of lipid-lowering therapies. Researchers continue to evaluate the long-term clinical impacts of obicetrapib through the ongoing PREVAIL cardiovascular outcomes trial.
If you are managing primary hypercholesterolaemia and feel your current treatment plan is not providing the necessary results, these new options may be worth discussing with your physician. They provide an alternative for patients who have struggled to reach their LDL-C goals with existing therapies.
The takeaway
The approval of Ubeslo and Evlarco introduces new treatment paths for those needing more effective cholesterol management. Patients should continue to monitor their LDL-C levels and talk to their doctor about whether these new medications align with their personal cardiovascular care plan.
Further reading
Learn more about the latest developments in Heart Disease.
More information
Review the full Ubeslo summary of product characteristics on the European Medicines Agency portal.
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