European regulator CHMP recommends approval of obicetrapib, the first CETP inhibitor

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive recommendation for two oral medicines based on the CETP inhibitor obicetrapib—Ubeslo (obicetrapib alone) and Evlarco (ob icetrapib combined with ezetimibe). Phase‑3 trials showed the monotherapy lowered LDL‑cholesterol by up to 40% and the fixed‑dose combination reduced LDL by roughly 50% compared with placebo, with safety comparable to placebo.

If the European Commission follows the CHMP’s advice later this year, obicetrapib would become the first CETP inhibitor to receive regulatory approval in Europe, offering a new oral treatment option for patients whose cholesterol remains high despite statins or who cannot use injectable therapies. The drug is being commercialized by Italian pharma group Menarini, which holds European rights from Dutch developer NewAmsterdam Pharma, marking a revival of a class that saw repeated failures over the past two decades.