Menarini Group and NewAmsterdam Pharma Gain EU Approval for Ubeslo and Evlarco

Menarini Group and NewAmsterdam Pharma Celebrate EU Approval for Ubeslo and Evlarco

In a groundbreaking achievement, Menarini Group and NewAmsterdam Pharma have announced that the European Commission has granted marketing authorization for their innovative medicines, Ubeslo® and Evlarco®. This approval represents a significant advancement for patients suffering from primary hypercholesterolemia, encompassing both heterozygous familial hypercholesterolemia (HeFH) and non-familial or mixed dyslipidemia.

Ubeslo is a monotherapy consisting of 10 mg of obicetrapib, while Evlarco is a fixed-dose combination therapy that includes 10 mg of obicetrapib alongside 10 mg of ezetimibe. The launch of these therapies is a monumental step, as obicetrapib becomes the first of its kind to receive global regulatory approval. The news heralds a new treatment option for those struggling to achieve optimal LDL cholesterol levels, particularly individuals who have not found sufficient relief with existing therapies.

Dr. Michael Davidson, CEO of NewAmsterdam Pharma, expressed the importance of this milestone during a recent press conference, stating, “The approval of Ubeslo and Evlarco by the European Commission marks an important milestone for NewAmsterdam, as it is the first global regulatory authorization for obicetrapib—a novel oral therapy. This decision validates our years of focused efforts to offer a new treatment option for patients continuing to struggle to reach recommended LDL cholesterol levels despite current available therapies.” He emphasized the company’s dedication to addressing unmet needs in cardiovascular medicine.

The marketing approval was informed by comprehensive data from pivotal clinical trials, including the Phase 3 BROADWAY, BROOKLYN, and TANDEM studies, which demonstrated statistically significant reductions in LDL cholesterol levels of up to 40% with the monotherapy and approximately 50% with the combination treatment compared to placebo. Notably, both Ubeslo and Evlarco exhibited favorable tolerability profiles, comparable to that of a placebo, providing further confidence in their safety and efficacy for patients.

NewAmsterdam and Menarini are committed to advancing the development of obicetrapib and have several ongoing Phase 3 trials, including PREVAIL – aimed at assessing cardiovascular outcomes. Elcin Barker Ergun, CEO of Menarini Group, shared her eagerness to incorporate these medications into the hands of healthcare professionals across Europe. “This approval signifies a major advancement for patients across Europe who require additional LDL cholesterol reduction despite currently available therapies,” she remarked.

Under the licensing agreement between Menarini and NewAmsterdam, Menarini holds exclusive marketing rights for obicetrapib in Europe. The company takes charge of regulatory management and marketing within this region. In exchange, NewAmsterdam stands to earn tiered royalties based on net sales within the territory, in addition to potential milestone payments totaling up to €833 million based on meeting certain clinical, regulatory, and commercial milestones.

As cardiovascular diseases continue to be a leading cause of mortality worldwide, the availability of innovative treatments like Ubeslo and Evlarco could markedly improve patient outcomes. By 2050, it is projected that more than 184 million adults in the United States will be affected by cardiovascular diseases, further underscoring the necessity for effective lipid-lowering therapies. With over 30 million Americans currently undertreated, the importance of new medication options cannot be overstated.

The advancements made by Menarini Group and NewAmsterdam Pharma could potentially reshape standards of care in cardiometabolic health. With thorough research and dedication to patient well-being, these companies are not only pushing boundaries in pharmaceutical development but also providing hope to those with unmet medical needs.

For more about the approved indications, contraindications, and warnings regarding Ubeslo and Evlarco, please find the Summary of Product Characteristics (SmPC) available on the European Medicines Agency website.