European Commission clears Ubeslo and Evlarco — first global marketing authorisation for the CETP inhibitor obicetrapib.

NewAmsterdam Pharma Company N.V. and Menarini Group announced on Monday, 21 September 2026, that the European Commission had granted marketing authorisation for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination) for patients with primary hypercholesterolaemia — heterozygous familial and non-familial — or mixed dyslipidaemia, according to the companies’ joint PR Newswire release opened for this pack. Soft FLAG: the release characterises the decision as the first regulatory approval of obicetrapib worldwide and as “first-in-class” — company framing, attribute.

The mechanism is CETP inhibition orally once daily. Soft FLAG: the company release describes obicetrapib as a novel, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor developed to lower LDL-C when existing therapies are not sufficiently effective or well tolerated. Soft FLAG: the EC approval follows a positive CHMP opinion, the release states. Soft FLAG: full SmPC details are pointed to future EMA EPAR pages for Ubeslo and Evlarco — those SmPC pages were not opened with complete labelled text in this run; rely on the company release for indication language and soft-FLAG hard clinical percentages.

Named trial evidence as the company release states it: authorisation is supported by Phase 3 BROADWAY, BROOKLYN and TANDEM, which the companies say demonstrated statistically significant LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with obicetrapib combined with ezetimibe versus placebo, with a tolerability profile comparable to placebo. Soft FLAG: those percentages and “comparable to placebo” tolerability language are company characterisations of the trials — attribute; independent EMA assessment documents not opened beyond the company pointer. Soft FLAG: NewAmsterdam says it continues Phase 3 PREVAIL (cardiovascular outcomes), REMBRANDT and RUBENS — outcomes data not claimed as part of this EC decision.

Commercial path: under the parties’ licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe and handles regional regulatory and commercial activity; NewAmsterdam is entitled to tiered double-digit royalties from low double-digits to mid-twenties on net sales in the Menarini territory and up to an additional €833 million in clinical, regulatory and commercial milestones, the release states. Soft FLAG: milestone and royalty bands are company contract colour.

Named voices in the opened release: NewAmsterdam CEO Michael Davidson called the EC decision “the first regulatory approval of obicetrapib globally” and a validation of years of work on an oral option for patients still missing LDL-C goals; Menarini CEO Elcin Barker Ergun framed it as an advancement for European patients who need additional LDL-C lowering despite available therapies. Soft FLAG: both quotes are company press language.

Disease-burden colour in the same release (attribute, not desk epidemiology): the companies cite cardiovascular disease as the leading global cause of death despite lipid-lowering therapies, and U.S.-centric figures on under-treated adults and LDL-C goal attainment — Soft FLAG: those prevalence and prescription counts are company background, not EU label claims, and are not independently verified in this pack.

Trial identifiers listed in the release for readers who want the registry trail: BROADWAY (NCT05142722), BROOKLYN (NCT05425745), TANDEM (NCT06005597), PREVAIL (NCT05202509), among others. Soft FLAG: NCT numbers are as printed in the company release.

What to watch without mood: EMA SmPC publication and first EU launches; PREVAIL MACE readout; any FDA path for the same molecule (not claimed in the opened release as approved).

Floor: EC marketing authorisation 21 Sep 2026 — Ubeslo (obicetrapib 10 mg) + Evlarco (obicetrapib/ezetimibe 10/10) for primary hypercholesterolaemia / mixed dyslipidaemia (company PR); first global obicetrapib approval per NewAmsterdam/Menarini; Phase 3 LDL-C cuts up to ~40% mono / ~50% combo vs placebo (co.); Menarini EU rights.