European Commission approves obicetrapib therapies for high LDL-C
NewAmsterdam and Menarini announced that the European Commission has authorized Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe), constituting the first regulatory approvals worldwide for obicetrapib. The decision follows a positive CHMP opinion and Phase 3 BROADWAY, BROOKLYN and TANDEM data showing LDL-C reductions up to 40% with monotherapy and approximately 50% with the combination, with tolerability comparable to placebo. Menarini holds exclusive European commercialization rights and NewAmsterdam is entitled to tiered royalties plus up to €833 million in milestones, while PREVAIL and other Phase 3 trials continue.
The EU approved obicetrapib-based Ubeslo and Evlarco for high LDL-C.
Context
The EMA committee gave a positive opinion based on Phase 3 trial data. The European Commission then issued marketing authorizations for the two formulations. Menarini will manage regulatory and commercial work in Europe while ongoing Phase…
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