#Italy #Florence #Menarini Group #Obicetrapib #Ezetimibe

Menarini Group's Obicetrapib and Ezetimibe Now Under EMA Review

The European Medicines Agency (EMA) has accepted the market authorization applications for Menarini Group's obicetrapib and the obicetrapib/ezetimibe combination treatment aimed at adults suffering from primary hypercholesterolemia and mixed dyslipidemia. This significant milestone could lead to the world's first availability of a CETP inhibitor that functions alongside dietary measures for patients who are unable to reach their low-density lipoprotein cholesterol (LDL-C) targets using maximum tolerated doses of statins. Moreover, it will benefit patients intolerant to statins or those for whom statins are contraindicated.

If granted approval, obicetrapib will be a key player in the pharmaceutical market, addressing the pressing need for effective cholesterol-lowering treatments. Menarini's CEO, Elcin Barker Ergun, emphasized the urgent requirement for additional therapeutic options in light of the increasing cardiovascular disease (CVD) mortality, which currently stands at around 17.9 million deaths annually worldwide, despite existing treatments.

The efficacy of obicetrapib is backed by pivotal phase 3 clinical trial results from studies named BROOKLYN and BROADWAY. These studies demonstrated statistically significant improvements in cholesterol reduction when using obicetrapib alongside maximally tolerated lipid-lowering treatments compared to placebo groups. The independent validation of these data is crucial not only for patient welfare but also for the Pharma industry targeting cardiovascular health improvements.

Clinical Study Insights

In the BROOKLYN (NCT05425745) and BROADWAY (NCT05142722) trials, obicetrapib stood out, revealing a remarkable capacity to lower LDL-C levels effectively. The supporting study on the fixed-dose combination of obicetrapib and ezetimibe (TANDEM, NCT06005597) also showcased a significant difference in efficacy over placebo and other treatments, reinforcing the relevance of this new therapeutic pathway for patients struggling with cholesterol management.

Furthermore, Menarini has mandated a heart outcomes phase 3 study known as PREVAIL, initiated in March 2022. Designed to assess the capacity of obicetrapib to lower major adverse cardiovascular events among patients at high risk, PREVAIL aims to gather further evidence of the product's long-term benefits and safety profile.

The Impact of Chronic Cholesterol Management

Cholesterol management has been a persistent challenge, with many patients not achieving their LDL-C goals even on statin therapy. Obicetrapib represents a new class of treatment—an oral CETP inhibitor that is administered once daily in a low-dose regimen. This pharmaceutical development may bridge the crucial treatment gap, offering both efficacy in cholesterol reduction and improved adherence for patients due to its convenient administration.

Menarini Group holds licenses for obicetrapib and the combination therapy in Europe, the UK, and Switzerland, having acquired them from NewAmsterdam Pharma in June 2022. The move underlines the company’s commitment to tackling unmet medical needs, particularly in primary care and specialized markets involving cardiology, gastroenterology, and oncology.

In conclusion, the approval of obicetrapib would not just be a major victory for Menarini Group but also a vital advancement in the fight against cholesterol-related cardiovascular diseases. The positive outcomes from clinical trials offer hope for millions worldwide who struggle to manage their cholesterol levels effectively. If successful, obicetrapib could transform standard treatment protocols, significantly improving patient outcomes and quality of life.