European Commission approves NewAmsterdam’s Ubeslo and Evlarco in EU
The European Commission approved Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib plus ezetimibe fixed-dose combination) for NewAmsterdam Pharma and Menarini, supported by Phase 3 BROADWAY, BROOKLYN and TANDEM trials showing LDL-C reductions and favorable tolerability.
The European Commission has approved NewAmsterdam’s Ubeslo and Evlarco in the EU, with the decision supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials that showed significant LDL-C reductions and a favorable tolerability profile. The approval is the first global regulatory approval of obicetrapib and marks a milestone for NewAmsterdam and Menarini, expanding treatment options.