Menarini Group and NewAmsterdam Pharma Win European Commission Approval for Obicetrapib
核心洞察
The European Commission granted marketing authorization for Ubeslo (搜索) (obicetrapib 10 mg monotherapy) and Evlarco (搜索) (obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination).
Approval covers primary hypercholesterolaemia (搜索), both heterozygous familial and non-familial or mixed dyslipidaemia (搜索), and is the first regulatory approval of obicetrapib worldwide.
The decision follows a positive CHMP opinion and Phase 3 BROADWAY, BROOKLYN and TANDEM data showing LDL-C reductions up to 40% versus placebo and about 50% with ezetimibe.
The European Commission has granted marketing authorization for Ubeslo (搜索) (obicetrapib 10 mg monotherapy) and Evlarco (搜索) (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination) in patients with primary hypercholesterolaemia (搜索), both heterozygous familial and non-familial or mixed dyslipidaemia (搜索). The decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and marks the first regulatory approval of obicetrapib worldwide.
The approval is supported by NewAmsterdam Pharma (搜索)'s Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which showed statistically significant LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with obicetrapib plus ezetimibe versus placebo, with a tolerability profile comparable to placebo. Obicetrapib is an oral, low-dose, once-daily CETP (搜索) inhibitor. Development continues in the Phase 3 PREVAIL cardiovascular outcomes trial, which randomized over 9,500 patients and completed enrollment in April 2024, as well as REMBRANDT and RUBENS.
Under the licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe and is responsible for regulatory interactions and commercialization across the region. NewAmsterdam is entitled to tiered double-digit royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini territory, plus up to an additional €833 million on achievement of clinical, regulatory and commercial milestones.
Source: PR Newswire