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

Menarini Group's Obicetrapib and Ezetimibe Applications Accepted by EMA

The Menarini Group, a prominent pharmaceutical company based in Italy, recently announced significant advancements regarding their new drug, Obicetrapib. This medication, along with its fixed-dose combination with Ezetimibe, has received validation from the European Medicines Agency (EMA). The applications for marketing authorization aim to provide new treatment options for adults suffering from primary hypercholesterolemia, both familial and non-familial, as well as mixed dyslipidemia. If sanctioned, Obicetrapib would mark a pivotal entry as the first Selective Cholesteryl Ester Transfer Protein (CETP) inhibitor available in Europe, effectively expanding treatment alternatives for patients who have difficulty achieving targeted cholesterol levels.

Obicetrapib is being marketed as an adjunct to diet, especially for patients who remain unable to meet low-density lipoprotein cholesterol (LDL-C) targets despite maximum tolerated doses of statins or those who experience statin intolerance or contraindications. The EMA's validation indicates that the application is complete and sets the stage for an in-depth centralized review.

Elcin Barker Ergun, the CEO of Menarini Group, stated the urgency for new therapeutic options in light of cardiovascular diseases, which remain the leading global cause of mortality, responsible for approximately 17.9 million deaths annually. Despite advances in lipid-lowering therapies, many patients still do not reach their LDL-C goals, highlighting the necessity for effective solutions. The anticipated approval of Obicetrapib could provide an innovative oral therapy for hypercholesterolemia, catering to a critical unmet need in cardiovascular health management.

The Clinical Evidence Supporting Obicetrapib

The validation from EMA is supported by robust results derived from pivotal Phase 3 studies: BROOKLYN and BROADWAY, both coordinated by NewAmsterdam Pharma. These studies indicated a statistically significant efficacy of Obicetrapib when used in conjunction with the most tolerable lipid-lowering therapies compared to a placebo. This compelling clinical evidence promises to reinforce the potential of Obicetrapib as a key player in the management of elevated cholesterol levels.

In terms of the combined therapy, the results from the TANDEM study, which also favors the Obicetrapib/Ezetimibe combination, provide further optimistic backing for the product. This fixed-dose combination demonstrates not only statistical superiority over each component separately but also a significant advantage when compared to other marketed therapies.

Ongoing Research and Future Directions

Menarini Group continues its commitment to advancing cardiovascular treatment through ongoing research, evidenced by the Phase 3 PREVAIL trial initiated in March 2022. This trial seeks to understand the capacity of Obicetrapib to mitigate significant cardiovascular events among patients positioned at exceptionally high cardiovascular risk. With enrollment completion recorded by April 2024, over 9,500 participants have been involved in this large-scale investigation, which holds promise for the future of cardiovascular disease management.

Moreover, NewAmsterdam Pharma, which licensed the rights for Obicetrapib and its combination treatment with Ezetimibe to Menarini in June 2022, has laid a strong groundwork through their successful completion of vital studies. This collaboration has the potential to reshape treatment landscapes for patients globally, as both companies aim to facilitate broader access to innovative therapies in Europe, the UK, and Switzerland.

Conclusion

Obicetrapib stands at the forefront of a new chapter in the pharmacological management of hypercholesterolemia and related cardiovascular risks. Menarini Group’s dedication to addressing unmet medical needs reflects the fervent hope of many patients seeking effective solutions for managing their lipid profiles. As the EMA moves forward with its review, the potential for Obicetrapib to enter market circulation presents an exciting opportunity to further combat one of the leading health challenges of our time. Continued monitoring of its progress will be essential as Menarini envisions bringing this promising option to patients who stand to benefit the most from its effects.