#Italy #Florence #Menarini Group #Obicetrapib #Ezetimibe

Menarini Group's Obicetrapib Advances in Cholesterol Management

On September 3, 2025, the Menarini Group announced that the European Medicines Agency (EMA) has accepted its application for the approval of Obicetrapib and Obicetrapib/Ezetimibe. This news is significant as it marks a vital step in the treatment of adults suffering from primary hypercholesterolemia, including both heterozygous familial and non-familial forms, as well as mixed dyslipidemia. If approved, Obicetrapib, licensed from NewAmsterdam Pharma, could become the first available CETP inhibitor used as an adjunct to diet for patients struggling to reach LDL cholesterol targets despite the maximum tolerated dose of statins or those who cannot tolerate statins.

What Is Obicetrapib?

Obicetrapib is an innovative oral CETP inhibitor designed to lower LDL cholesterol levels. It's administered in a low-dose regimen once daily, aimed primarily at patients who are unable to adequately manage their cholesterol levels with existing treatments. Recent studies have shown that over 100 million individuals globally do not achieve target LDL levels using standard therapies, underlining the need for additional effective treatment alternatives.

The clinical efficacy of Obicetrapib is supported by data from pivotal Phase III trials, including BROOKLYN and BROADWAY, where it demonstrated superior efficacy in lowering LDL-C when combined with lipid-lowering therapies compared to placebo. The Obicetrapib/Ezetimibe combination has also shown statistically significant advantages in trials including the TANDEM study, which pitted it against individual placebo and other standard treatments.

The Need for New Options

Elcin Barker Ergun, CEO of Menarini Group, highlighted the gravity of cardiovascular diseases, stating that they account for approximately 17.9 million deaths annually. Despite the availability of lipid-lowering treatments, mortality rates from cardiovascular diseases continue to rise as many patients struggle to meet the recommended LDL cholesterol levels. This situation underscores the necessity for alternative treatment options.

“That’s why Obicetrapib could offer a viable and safe oral option for patients with hypercholesterolemia if approved,” Ergun said. Menarini is eager to collaborate with the EMA to potentially bring this new therapy to market for patients in need.

Supporting Research and Trials

The BROOKLYN, BROADWAY, and TANDEM studies assessed Obicetrapib and its combination with Ezetimibe in conjunction with maximum tolerated doses of lipid-lowering therapies against placebo in patients not achieving target LDL-C levels. The findings from the BROADWAY and TANDEM trials have been published in reputable journals such as NEJM and The Lancet, further validating the claims of Obicetrapib's safety and efficacy in treating high cardiovascular risk patients with hypercholesterolemia.

A Phase III cardiovascular outcomes study, PREVAIL, began in March 2022 to evaluate the impact of Obicetrapib in reducing major adverse cardiovascular events among patients at high cardiovascular risk due to hypercholesterolemia, with enrollment concluded in April 2024, including over 9,500 patients.

Conclusion

The Menarini Group, with over $4.5 billion in sales and more than 17,000 employees, operates globally, focusing on meeting healthcare needs in cardiology, oncology, and other therapeutic areas. Their commitment to addressing substantial unmet needs in hypercholesterolemia makes the approval of Obicetrapib a potentially groundbreaking development in cardiovascular health. For more details, visit Menarini’s website or learn more about NewAmsterdam Pharma here.