EC approves Menarini and NewAmsterdam’s obicetrapib therapies

The European Commission has approved two new medicines containing obicetrapib: Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (combination of obicetrapib 10 mg with ezetimibe 10 mg). These medicines are intended for patients with primary hypercholesterolaemia, including heterozygous familial and non-familial forms or mixed dyslipidaemia. This is the first regulatory approval of obicetrapib worldwide. Phase III clinical trials (BROADWAY, BROOKLYN, and TANDEM) demonstrated that obicetrapib monotherapy reduces LDL cholesterol by up to 40% compared to placebo, while the combination with ezetimibe reduces it by approximately 50%. The safety profile was similar to placebo. Menarini holds exclusive marketing rights for obicetrapib in Europe, and NewAmsterdam will receive double-digit royalties with potential milestone payments of up to €833 million.