NewAmsterdam Pharma Company N.V.

Menarini Group and NewAmsterdam Pharma Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)

NewAmsterdam Pharma and partner Menarini Group received European Commission marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (obicetrapib plus ezetimibe fixed-dose combination), marking the first regulatory approval of obicetrapib worldwide. The approval covers patients with primary hypercholesterolaemia, both heterozygous familial and non-familial or mixed dyslipidaemia, and is supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM data showing LDL-C reductions of up to 40% on monotherapy and roughly 50% with the combination versus placebo, with a tolerability profile comparable to placebo. Under the licensing agreement, Menarini holds exclusive European commercialization rights and NewAmsterdam is entitled to tiered double-digit royalties — from the low double-digits to mid-twenties — on net sales in the Menarini Territory, plus up to an additional €833 million in clinical, regulatory, and commercial milestones. Obicetrapib remains in late-stage development, including the PREVAIL cardiovascular outcomes trial with over 9,500 patients randomized, leaving US approval and outcomes data as the next major catalysts for the company.

•1mo ago

NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)

NewAmsterdam Pharma and partner Menarini Group announced a positive CHMP opinion recommending marketing authorization for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib/ezetimibe FDC) in Europe. The recommendation is backed by Phase 3 data showing LDL-C reductions of up to 50%, with a final European Commission decision expected in the second half of 2026. Menarini holds exclusive commercialization rights in Europe, while NewAmsterdam is eligible for tiered royalties ranging from the low double-digits to mid-twenties and up to €833 million in milestones.

•3mo ago