EU approves NewAmsterdam and Menarini's obicetrapib drugs

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Go back to EU approves NewAmsterdam and Menarini's obicetrapib drugs

NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)

September 21, 2026 9:00 AM EDT

- First-in-Class approval supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant LDL-C reductions with favorable tolerability profile-

- First global regulatory approval of obicetrapib marks a defining milestone for NewAmsterdam and Menarini, expanding treatment options for patients with elevated LDL-C -

NAARDEN, The Netherlands and MIAMI and FLORENCE, Italy, Sept. 21, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or NewAmsterdam or the Company), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C), for whom existing therapies are not sufficiently effective... More