Late-stage biopharmaceutical company NewAmsterdam Pharma Company N.V. (Nasdaq:NAMS) and its partner Menarini Group announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (FDC)) for patients with primary hypercholesterolemia, both heterozygous familial (HeFH) and non-familial or mixed dyslipidaemia.

The positive CHMP recommendation is supported by data from NewAmsterdam's clinical development programme evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which demonstrated statistically significant LDL-C reductions up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with obicetrapib combined with ezetimibe versus placebo, with a tolerability profile comparable to placebo.

NewAmsterdam and Menarini are continuing to advance the clinical development of obicetrapib through ongoing Phase 3 trials, including PREVAIL, a cardiovascular outcomes trial, as well as REMBRANDT and RUBENS.

The CHMP's positive opinion will now be reviewed by the European Commission, which is expected to adopt a final decision on marketing authorisation and has authority to grant centralised marketing authorisation applicable across all European Union member states, as well as Iceland, Liechtenstein and Norway.

Under a licensing agreement, Menarini holds exclusive commercialisation rights for obicetrapib in Europe, and is responsible for regulatory interactions and commercialisation activities throughout the region. NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini territory, and up to an additional EUR833m upon the achievement of various clinical, regulatory and commercial milestones.