CHMP recommends marketing authorization for Ubeslo® and Evlarco® in Europe
The European Medicines Agency's CHMP has issued a positive opinion recommending marketing authorization for NewAmsterdam Pharma and Menarini's drugs Ubeslo® and Evlarco®. A final decision from the European Commission is expected in the second half of 2026.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization for Ubeslo® (obicetrapib as monotherapy) and Evlarco® (a fixed-dose combination of obicetrapib and ezetimibe). The recommendation is for the treatment of primary hypercholesterolemia in patients for whom existing therapies are insufficient or not well-tolerated.
The positive opinion is based on results from Phase III clinical trials, including BROADWAY, BROOKLYN, and TANDEM. These studies demonstrated that obicetrapib as monotherapy reduced LDL-cholesterol by up to 40% compared to placebo, while the combination with ezetimibe achieved reductions of approximately 50%.
Following the CHMP recommendation, the European Commission will review the application. A final decision on the centralized marketing authorization, valid across EU member states, Iceland, Liechtenstein, and Norway, is anticipated in the second half of 2026.
Under their agreement, Menarini will hold exclusive rights to market obicetrapib in Europe, with NewAmsterdam Pharma set to receive tiered royalties and potential milestone payments based on commercial success.