#Italy #Florence #Menarini Group #Obicetrapib #CETP inhibitor

Menarini Group's Proposal to EMA for Obicetrapib Registration

In an important development for cholesterol management, the European Medicines Agency (EMA) has received a request from Menarini Group for the registration of Obicetrapib and its combination with Ezetimibe. This proposal specifically targets adults suffering from primary hypercholesterolemia, including heterozygous familial and non-familial forms, as well as those facing mixed dyslipidemia.

Obicetrapib, developed by NewAmsterdam Pharma, is a selective inhibitor of cholesteryl ester transfer protein (CETP). If approved, it would be the first available CETP inhibitor as a dietary supplement for patients who struggle to meet low-density lipoprotein cholesterol (LDL-C) targets, particularly those unable to achieve these levels while on the highest tolerated dose of statins or those who cannot tolerate statins at all.

This registration request is backed by the notable results from key Phase 3 studies named BROOKLYN, BROADWAY, and TANDEM. These studies provide significant evidence of the efficacy of Obicetrapib and Obicetrapib/Ezetimibe in conjunction with maximum tolerated doses of lipid-lowering therapies compared to placebo.

Investigative Studies Highlighting Effectiveness

The BROOKLYN and BROADWAY studies demonstrated statistically significant reductions in LDL-C levels among patients treated with Obicetrapib, either alone or combined with Ezetimibe. Furthermore, the TANDEM study illustrated a notable difference in effectiveness between the fixed-dose combination and the standard treatment levels, emphasizing Obicetrapib's potential. Both BROADWAY and TANDEM findings have been published in prestigious journals like the New England Journal of Medicine and The Lancet.

According to Menarini's CEO, Elcin Barker Ergun, cardiovascular diseases remain a leading global cause of mortality, resulting in approximately 17.9 million deaths annually. Despite the availability of lipid-lowering treatments, a significant number of patients still do not reach their LDL-C targets. This unmet need for effective treatments underscores the importance of developing further options for patients.

Safety and Acceptability of Obicetrapib

Studies have indicated that Obicetrapib not only achieves statistically significant LDL-C reductions but also does so with a favorable safety profile. It is critical in addressing the gap where over 100 million individuals worldwide fail to meet LDL-C targets, even with current treatment standards. Given the pressing need for effective and well-tolerated therapies, Obicetrapib could truly revolutionize care for those with hypercholesterolemia.

Menarini's acquisition of rights for Obicetrapib in Europe, the UK, and Switzerland in June 2022 was predicated upon the successful completion of these pivotal studies by NewAmsterdam Pharma. This move further emphasizes Menarini's dedication to addressing significant health challenges in the field of cholesterol management.

Future Prospects for Patients

The company anticipates that, pending approval from the EMA, Obicetrapib could provide an effective oral treatment alternative for patients struggling with hypercholesterolemia. As they work closely with regulatory bodies, the hope is to expedite access to this potentially life-changing therapy, improving health outcomes for patients who are currently underserved by existing options.

Menarini Group prides itself on being at the forefront of pharmaceutical innovation, with a strong commitment to addressing serious health needs across various fields including cardiology, oncology, and beyond. With over 4.5 billion dollars in revenue and a workforce exceeding 17,000 employees, Menarini continues to make strides in developing critical medications for pressing health concerns.