European Commission Approved Ubeslo and Evlarco
The authorization marks the first global regulatory approval for the cholesterol-lowering medication obicetrapib.
Updated on Sept. 21, 2026 in Heart Disease
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The European Commission has granted marketing authorization for Ubeslo and Evlarco to treat patients with primary hypercholesterolaemia and mixed dyslipidaemia. These therapies offer new options for individuals whose current treatments for elevated LDL-C levels are not sufficiently effective or well-tolerated.
Why it matters
This approval provides a significant new therapeutic pathway for patients struggling to manage high cholesterol who have not found success with existing standard-of-care treatments. It also establishes a major regulatory milestone for obicetrapib as developers continue to evaluate its long-term cardiovascular outcomes.
Clinical trials showed obicetrapib monotherapy reduced LDL-C by up to 40% compared to placebo, while the combination with ezetimibe achieved an approximate 50% reduction. Both Ubeslo and Evlarco utilize a standard 10 mg dosage of obicetrapib.
The players
European Commission
The executive branch of the European Union that is responsible for proposing legislation and implementing decisions.
NewAmsterdam Pharma
A clinical-stage biopharmaceutical company based in Naarden, The Netherlands, focused on developing therapies for metabolic diseases.
Menarini Group
An Italian pharmaceutical and diagnostics company headquartered in Florence that manages commercialization for various health products.
The details
Ubeslo consists of 10 mg obicetrapib monotherapy, while Evlarco provides a fixed-dose combination of 10 mg obicetrapib and 10 mg ezetimibe. NewAmsterdam Pharma holds rights to milestone payments reaching up to €833 million as the Menarini Group moves to commercialize the drugs across Europe.
Timeline
March 2022 marked the commencement of the Phase 3 PREVAIL cardiovascular outcomes trial.
April 2024 saw the completion of enrollment for the 9,500-patient PREVAIL trial.
September 21, 2026, is the date the European Commission issued the marketing authorization.
The Big Picture
This regulatory milestone follows the trajectory set by the Phase 3 PREVAIL cardiovascular outcomes trial regarding the efficacy of new cholesterol-lowering agents. The approval formalizes the clinical utility of obicetrapib for patients who have not reached their cholesterol targets with standard treatments.
Patients with primary hypercholesterolaemia or mixed dyslipidaemia may soon gain access to these new 10 mg therapies if their existing treatments prove insufficient. Doctors will be able to prescribe these options once they are officially distributed by the Menarini Group in the European market.
The takeaway
The arrival of these two therapies introduces a novel mechanism for managing LDL-C levels that may assist patients resistant to common cholesterol medications. This development highlights the ongoing shift toward specialized, fixed-dose combination treatments in cardiovascular health.
Further reading
Learn more about advancements in managing Heart Disease.
More information
Review the Ubeslo summary of product characteristics for detailed clinical information.
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