Posted by Michael Wonder on 26 Jul 2026
NewAmsterdam Pharma and Menarini receive positive CHMP opinion recommending marketing authorisation for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib plus ezetimibe fixed dose combination)
24 July 2026 - Recommendation based on positive Phase 3 BROADWAY, BROOKLYN, and TANDEM data.
NewAmsterdam Pharma along with partner Menarini today announced that the CHMP of the EMA has adopted a positive opinion recommending marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (10 mg obicetrapib with 10 mg ezetimibe fixed-dose combination for patients with primary hypercholesterolaemia, both heterozygous familial and non-familial or mixed dyslipidaemia.
