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

Menarini Group's Obicetrapib Receives EMA Review Approval

In an exciting development for cardiovascular health, the Menarini Group announced that the European Medicines Agency (EMA) has accepted their marketing authorization application (MAA) for Obicetrapib, a novel treatment targeting adults with primary hypercholesterolemia. This includes both heterozygous familial and non-familial forms, as well as patients with mixed dyslipidemia. If approved, Obicetrapib will become the first cholesterol ester transfer protein (CETP) inhibitor licensed for use alongside diet for those struggling to meet their low-density lipoprotein cholesterol (LDL-C) goals through conventional statin therapy.

Obicetrapib holds particular promise for patients who are unable to achieve their LDL-C targets while on the highest tolerated doses of statins or for those who cannot tolerate statins due to adverse effects or contraindications. According to Elcin Barker Ergun, CEO of Menarini Group, despite the widespread availability of lipid-lowering therapies, cardiovascular diseases remain the leading cause of death globally, attributing to approximately 17.9 million deaths annually. This highlights a critical need for additional treatment options for patients and their healthcare providers.

Menarini’s application is supported by several pivotal phase-3 clinical trials led by NewAmsterdam Pharma, which demonstrated statistically significant effectiveness of Obicetrapib when used in conjunction with the maximum tolerated lipid-lowering therapy compared to placebo. The trials, including BROOKLYN and BROADWAY, showcased compelling data that could position Obicetrapib as a vital tool in managing high cholesterol levels. Furthermore, the combination therapy Obicetrapib/Ezetimibe, also undergoing review, showed favorable outcomes improving lipid panels beyond what Ezetimibe alone accomplished. These studies affirm that Obicetrapib could significantly impact patient care for those at high cardiovascular risk.

As the landscape of cholesterol management evolves, Obicetrapib represents potentially groundbreaking change in therapeutic strategy. Aside from its Cholesteryl Ester Transfer Protein inhibition mechanism, it is positioned as a once-daily oral medication that not only lowers LDL-C levels but could also mitigate severe cardiovascular risks associated with hypercholesterolemia. Over 100 million individuals globally have yet to meet their LDL-C goals despite being on traditional treatments, thus the introduction of Obicetrapib into the market could provide relief and better management for these patients.

Menarini Group is a privately held international pharmaceutical and diagnostic company based in Florence, Italy, with a robust annual revenue exceeding $4.5 billion, operating with more than 17,000 employees around the world. The company focuses on primary and specialty care sectors, oncology, and consumer health, addressing therapeutic areas with significant unmet medical needs.

The phase-3 studies BROOKLYN (NCT05425745), BROADWAY (NCT05142722), and TANDEM (NCT06005597) assessed Obicetrapib and Obicetrapib/Ezetimibe as adjunct therapies with lipid-lowering regimens. The results indicated that this new drug combination had a considerable and statistically significant reduction in LDL-C thresholds compared to existing treatments. With the patient enrollment of over 9,500 randomised subjects, the PREVAIL study (initiated in March 2022) investigated the long-term cardiovascular outcomes with Obicetrapib for individuals at elevated cardiovascular risk, aiming to deliver further clarity on its efficacy and safety.

By acquiring licensing rights from NewAmsterdam Pharma in June 2022, Menarini has taken proactive steps to ensure this promising medication reaches healthcare providers and patients across Europe, the UK, and Switzerland, paving the path for improved cholesterol management. As the EMA initiates its centralized review process for Obicetrapib, stakeholders are eager to see how this innovation might revolutionize treatment methodologies, providing healthcare professionals and patients with significant new possibilities for managing high cholesterol effectively.