NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion for Drug Approval
The European Medicines Agency's CHMP has recommended the approval of Ubeslo (Obicetrapib) and Evlarco (Obicetrapib/Ezetimib). A final decision from the European Commission is expected in the second half of 2026.
NewAmsterdam Pharma Company and its partner, the Menarini Group, have received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The opinion recommends the approval of Ubeslo® (Obicetrapib monotherapy) and Evlarco® (a fixed-dose combination of Obicetrapib and Ezetimib).
The CHMP's recommendation supports the potential market introduction of Obicetrapib monotherapy and the Obicetrapib/Ezetimib fixed-dose combination in Europe. These treatments are intended for patients with high LDL cholesterol and increased cardiovascular risk who have not met their treatment goals with existing therapies.
The recommendation is based on positive data from comprehensive Phase 3 clinical trials, including BROADWAY, BROOKLYN, and TANDEM. These studies demonstrated statistically significant reductions in LDL cholesterol, up to 40% for Obicetrapib monotherapy and approximately 50% for the combination therapy with Ezetimib compared to placebo, with a comparable safety profile.
The European Commission is expected to issue a final decision regarding the marketing authorizations in the second half of 2026. If approved, Menarini will be responsible for marketing these drugs across Europe.