The European Commission has granted marketing authorization for obicetrapib-based therapies Ubeslo and Evlarco, representing the first regulatory approval of the cholesterol drug anywhere in the world.
Ubeslo contains 10 mg of obicetrapib as a monotherapy, while Evlarco is a fixed-dose combination of 10 mg obicetrapib plus 10 mg ezetimibe. Both are approved for patients with primary hypercholesterolaemia, including heterozygous familial and non-familial forms, as well as mixed dyslipidaemia.
Obicetrapib is an oral, low-dose CETP inhibitor aimed at patients with elevated LDL-C for whom existing therapies have proven insufficient or poorly tolerated. Clinical data from the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials supported the approval, showing up to a 40% LDL-C reduction with obicetrapib monotherapy versus placebo, and approximately 50% reduction with the combination therapy versus placebo. The trials also demonstrated a tolerability profile comparable to placebo.
NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) holds the rights to the asset, while Menarini Group has exclusive commercialization rights for obicetrapib across Europe. Under their licensing agreement, NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales within the Menarini territory, and may receive up to an additional €833 million in milestone payments tied to clinical, regulatory, and commercial achievements.
Clinical development continues through several ongoing Phase 3 trials. The PREVAIL cardiovascular outcomes trial, which randomized over 9,500 patients, completed enrollment in April 2024. Additional Phase 3 studies include REMBRANDT and RUBENS.
