NewAmsterdam and Menarini Secure EU Approval for Obicetrapib Therapies

The approval covers Ubeslo, a 10 mg obicetrapib monotherapy, and Evlarco, a fixed-dose combination of 10 mg obicetrapib and 10 mg ezetimibe. These treatments are indicated for primary hypercholesterolaemia, including both heterozygous familial and non-familial or mixed dyslipidaemia. The regulatory decision follows positive opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use and draws on data from the Phase 3 BROADWAY, BROOKLYN, and TANDEM clinical trials.

Clinical results showed that obicetrapib monotherapy reduced LDL-C levels by up to 40% compared to placebo, while the combination with ezetimibe achieved reductions of approximately 50%. The drug demonstrated a tolerability profile comparable to placebo, offering a potential solution for patients who fail to meet LDL-C goals with existing medications. Menarini Group holds exclusive commercialization rights for the drugs in Europe and will lead regulatory and market activities, while NewAmsterdam Pharma remains eligible for tiered double-digit percentage royalties and potential milestone payments of up to €833 million.