#Italy #Florence #Menarini Group #Obicetrapib #Cholesterol Treatment

Menarini Group's Latest Advancements in Cholesterol Treatment

The Italian pharmaceutical company, Menarini Group, has made significant strides in the battle against hypercholesterolemia. On September 3, 2025, Menarini announced that the European Medicines Agency (EMA) has accepted its marketing authorization applications for both Obicetrapib and a fixed-dose combination of Obicetrapib and Ezetimibe. This promising development targets adults suffering from primary hypercholesterolemia, including both heterozygous familial and non-familial forms, or mixed dyslipidemia. These patients often struggle to achieve their low-density lipoprotein cholesterol (LDL-C) targets despite being on maximum tolerable statin therapy.

If approved, Obicetrapib will mark a significant milestone as the first CETP inhibitor available as a dietary adjunct for managing cholesterol levels. Menarini Group has emphasized the importance of providing additional options for patients who cannot achieve their LDL-C goals. The current state of cardiovascular health remains troubling; despite available lipid-lowering therapies, cardiovascular diseases continue to be the leading global cause of death, accounting for approximately 17.9 million fatalities each year.

Elcin Barker Ergun, CEO of Menarini Group, highlighted the urgency of developing new therapies: "Patients and their physicians require additional options." He expressed optimism that if Obicetrapib gains approval, it could serve as an effective oral alternative for those suffering from hypercholesterolemia.

Background on Obicetrapib

Obicetrapib is a next-generation oral CETP inhibitor designed to significantly reduce LDL-C levels and prevent serious adverse cardiovascular events. Current estimates suggest that over 100 million people worldwide struggle to reach their LDL-C goals despite existing medical treatments. The pivotal Phase 3 studies — BROOKLYN, BROADWAY, and TANDEM — have demonstrated statistically significant reductions in LDL-C levels when Obicetrapib is combined with the maximum tolerable lipid-lowering therapy compared to placebo. The findings from these studies have been published in renowned medical journals such as NEJM and The Lancet.

Both the standalone and combination therapies of Obicetrapib/Ezetimibe have shown promising results in clinical trials, establishing a strong safety profile and substantial LDL-C reduction. The trial data reinforces the potential of Obicetrapib in addressing a significant unmet medical need for patients with high cardiovascular risk.

Future Prospects

The ongoing Phase 3 PREVAIL study will further evaluate the cardiovascular effects of Obicetrapib on high-risk hypercholesterolemic patients. With over 9,500 patients randomized, the study aims to contribute critical data regarding the reduction of serious cardiovascular events. With the registration completion expected by April 2024, the anticipation for Obicetrapib’s potential approval is building.

The journey of Obicetrapib began when Menarini secured European rights from NewAmsterdam Pharma in June 2022. Following successful completion of the essential Phase 3 studies, the company has taken an assertive approach by filing two applications with the EMA — one for Obicetrapib and the other for its combination therapy with Ezetimibe.

About Menarini Group

Menarini Group is a prominent international pharmaceutical and diagnostic company with a revenue exceeding $4.5 billion and a workforce of over 17,000 employees. Specializing in primary and specialized care, oncology, and consumer healthcare, Menarini focuses on therapeutic areas with significant unmet medical needs, such as cardiology, oncology, and infectious diseases.

For further information, please visit Menarini's official website.