EU Commission approves NewAmsterdam Pharma’s obicetrapib for primary hypercholesterolemia

• EU regulators granted marketing authorization for Ubeslo (obicetrapib) and Evlarco (obicetrapib-ezetimibe) to treat primary hypercholesterolemia.
• Approval covers heterozygous familial or non-familial disease, also mixed dyslipidemia; first global clearance for obicetrapib.
• Phase 3 data showed up to 40% LDL-C reduction on monotherapy; about 50% with fixed-dose combination versus placebo.
• Menarini holds exclusive European commercialization rights; NewAmsterdam eligible for tiered double-digit royalties up to about 25%.
• Deal includes up to EUR 833 million in potential milestone payments tied to clinical, regulatory, commercial triggers.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NewAmsterdam Pharma Company NV published the original content used to generate this news brief via PR Newswire (Ref. ID: FR52664) on September 22, 2026, and is solely responsible for the information contained therein.