Menarini Group's Obicetrapib and Ezetimibe Await EMA Approval for Cholesterol Management

Menarini Group, the international pharmaceutical company based in Italy, has exciting news for patients struggling with high cholesterol. On September 2, 2025, the European Medicines Agency (EMA) accepted their applications for marketing authorization for Obicetrapib and its combination with Ezetimibe. This comes as a promising step towards providing effective treatment for adults facing primary hypercholesterolemia and mixed dyslipidemia who have not achieved their cholesterol goals despite existing therapies.

Obicetrapib, an oral medication designed to inhibit the cholesterol ester transfer protein (CETP), is positioned as a groundbreaking option for patients unable to reach the recommended LDL-C levels. This includes those who are intolerant to statins or cannot use them for medical reasons. If approved, it will be the first CETP inhibitor available as an adjunct to dietary measures, a significant advancement considering the rising numbers of cardiovascular diseases.

Significant Study Findings

This development is heavily supported by the positive outcomes from three pivotal Phase 3 studies: BROOKLYN, BROADWAY, and TANDEM. These trials demonstrated that Obicetrapib significantly outperforms placebo in terms of effectiveness when combined with lipid-lowering therapies. The studies showed a statistically significant reduction in LDL-C levels among participants, underscoring the potential of Obicetrapib as a vital alternative for patients struggling with high cholesterol levels.

The BROOKLYN trial, for instance, involved participants already on maximum tolerated doses of statins. Many of these patients were still unable to meet LDL-C targets set by recent treatment guidelines. As detailed in research published in respected medical journals such as the NEJM and The Lancet, both the trials BROADWAY and TANDEM showed that the combination of Obicetrapib and Ezetimibe produced substantial cholesterol reductions, confirming the drug's safety and efficacy.

Addressing a Global Health Concern

Elcin Barker Ergun, CEO of Menarini Group, articulated the urgency of introducing such an option, stating that cardiovascular diseases are the leading cause of death globally, accounting for approximately 17.9 million fatalities each year. Despite many currently available therapies, there has been an alarming increase in cholesterol-related deaths. This reality calls for innovative solutions and an expanded range of options for patients and healthcare providers.

Obicetrapib could potentially fill this gap by offering a new oral treatment that is both effective and safe. Its approval could mean that millions suffering from elevated cholesterol levels could finally have access to a more manageable solution that could lower their risk of heart-related health issues.

Completing the Regulatory Process

Following the initial validation of the marketing authorization requests, the EMA process now moves into the centralized review phase. Menarini acquired the rights for Obicetrapib and its combination with Ezetimibe from NewAmsterdam Pharma in June 2022. The continued development and research conducted by NewAmsterdam have laid a solid foundation for the regulatory approvals under consideration.

As the EMA reviews the applications, patient advocates, healthcare professionals, and the broader medical community await the agency's decision, hopeful that these novel treatments will soon transition from clinical trials to the hands of doctors and patients in need. Menarini Group is keen on collaborating closely with the EMA during this crucial period to expedite the process and bring these medications to market.

In Conclusion

With the increasing prevalence of high cholesterol and the associated health risks, the acceptance of Obicetrapib and Ezetimibe's marketing authorization applications by the EMA represents a significant potential advancement in patient care. Should they receive approval, these treatments could soon provide significant benefits for those managing hypercholesterolemia and mixed dyslipidemia, filling a critical need in cardiovascular health management.

For more information on Obicetrapib and Menarini Group, visit Menarini's official website.