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04 Sep 2025
Admin
News Article

EMA Accepts Menarini’s Marketing Applications for Obicetrapib and Obicetrapib/Ezetimibe

Menarini Group has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Applications (MAA) for:

Obicetrapib, a next-generation, low-dose CETP inhibitor.
Obicetrapib/Ezetimibe, a fixed-dose combination therapy.

Both are intended as dietary supplements for patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia who:

Cannot achieve LDL-C targets with the maximum tolerated dose of statins.
Are statin-intolerant.
Have contraindications to statin therapy.

The EMA’s acceptance confirms that the submissions are complete and initiates the centralized review procedure.

Clinical Evidence Supporting the Submission

The applications are based on pivotal Phase 3 clinical trials conducted by NewAmsterdam Pharma:

BROOKLYN (NCT05425745) – Assessed obicetrapib in combination with lipid-lowering agents vs placebo.
BROADWAY (NCT05142722) – Evaluated obicetrapib with maximally tolerated therapy vs placebo.
TANDEM (NCT06005597) – Studied obicetrapib/ezetimibe vs placebo, ezetimibe 10 mg, and obicetrapib 10 mg monotherapy.

Key results:

All three trials demonstrated statistically significant LDL-C reductions in favor of obicetrapib or the fixed-dose combination.
Results were published in The New England Journal of Medicine (NEJM) and The Lancet.
Obicetrapib showed a good safety profile across studies.

Additionally, the Phase 3 PREVAIL trial (NCT05254002), launched in March 2022, is assessing obicetrapib’s impact on major cardiovascular events in >9,500 high-risk patients. Recruitment completed in April 2024.

Leadership Perspective

Elcin Barker Ergun, CEO of Menarini Group:

“Cardiovascular disease is the leading cause of death worldwide, yet many patients remain above LDL-C targets despite current therapies. If approved, obicetrapib could represent an effective, safe oral option for patients with hypercholesterolemia. We look forward to working with the EMA to make this therapy available.”

About Obicetrapib

Mechanism: Selective cholesteryl ester transfer protein (CETP) inhibitor.
Dosing: Once-daily, low-dose oral therapy.
Goal: To significantly lower LDL-C and reduce risk of cardiovascular events.
Unmet need: Over 100 million people worldwide fail to achieve LDL-C goals under current standards of care.

Corporate Background

Menarini Group: Headquartered in Italy, with turnover >$4.5 billion and >17,000 employees. Operates 18 manufacturing plants and 9 R&D centers. Products reach 140 countries across key areas including cardiology, oncology, gastroenterology, and diabetology.
NewAmsterdam Pharma: Conducted the pivotal Phase 3 trials before licensing European, UK, and Swiss rights to Menarini in June 2022.

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