#Italy #Menarini #Florence #Obicetrapib #NewAmsterdam

European Commission Approves Ubeslo® and Evlarco®

In a groundbreaking development, the European Commission has granted marketing authorization for Ubeslo® and Evlarco®, two innovative treatments from NewAmsterdam Pharma Company in collaboration with the Menarini Group. This approval signifies the first global recognition of obicetrapib, aimed at lowering lipoprotein cholesterol (LDL-C) levels in patients who do not adequately respond to existing therapies.

Transformative Therapies for Cardiovascular Patients

NewAmsterdam Pharma, a clinical biopharmaceutical company focused on oral, non-statin medicines, announced that the approval encompasses patients with primary hypercholesterolemia, including both heterozygous familial (HeFH) and non-familial or mixed dyslipidemia. It is a crucial step in expanding treatment options for individuals at heightened risk of cardiovascular disease (CVD).

Michael Davidson, CEO of NewAmsterdam, emphasized that this milestone reflects years of dedicated research aimed at providing alternative therapies for patients struggling to achieve optimal LDL-C levels with current treatments. He remarked, "This first-in-class approval validates the strength of our clinical evidence and our commitment towards addressing a significant unmet need in cardiovascular medicine."

The approval was based on robust clinical data, particularly from the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials. These studies showed that obicetrapib monotherapy can significantly reduce LDL-C levels by up to 40% compared to placebo, while obicetrapib combined with ezetimibe achieved an impressive approximately 50% reduction, maintaining a tolerability profile comparable to placebo.

Commitment to Ongoing Research and Development

In addition to the newly approved therapies, NewAmsterdam and Menarini are pursuing further clinical development of obicetrapib through ongoing Phase 3 trials, including PREVAIL, which focuses on cardiovascular outcomes. The PREVAIL study aims to assess the potential of obicetrapib in reducing Major Adverse Cardiovascular Events (MACE) and has already enrolled over 9,500 patients.

Elcin Barker Ergun, CEO of Menarini, expressed pride in achieving this milestone alongside NewAmsterdam. He stated, "This approval represents a significant advancement for patients across Europe who require additional LDL-C lowering despite available therapies. Our established commercial capabilities will facilitate the distribution of Ubeslo and Evlarco to healthcare providers and eligible patients throughout Europe."

Under the licensing agreement, Menarini will manage the commercialization of obicetrapib in Europe, with NewAmsterdam entitled to royalties based on sales performance and milestones. This partnership reflects a commitment to leverage collective expertise in the field of cardiovascular health to enhance patient care.

Addressing the Global Burden of Cardiovascular Disease

Cardiovascular diseases remain a leading cause of mortality globally, with projections indicating that by 2050, over 184 million adults in the United States will be affected. Despite advancements in lipid-lowering therapies, achieving LDL-C target levels has been a challenge for many patients, resulting in an urgent need for new treatment avenues.

The approval of Ubeslo and Evlarco paves the way for enhancing treatment strategies for patients struggling with high LDL-C levels, thus addressing a critical need in cardiovascular medicine. With comprehensive research and collaborative efforts, NewAmsterdam and Menarini aspire to significantly improve the health outcomes of patients worldwide.

About NewAmsterdam and Menarini

NewAmsterdam Pharma, listed on Nasdaq, focuses on establishing new standards of care in cardiometabolic diseases. By emphasizing innovative therapies that prioritize effectiveness and tolerability, the company aims to meet the significant clinical demands of patients at risk for cardiovascular complications.

Meanwhile, Menarini Group, headquartered in Florence, is recognized for its global presence and dedication to high-quality manufacturing across diverse therapeutic areas, including cardiometabolic health. The company is committed to patient welfare through continuous investment in research and development.

In summary, the European Commission's approval of Ubeslo and Evlarco heralds a new era for LDL-C management, promising to benefit patients grappling with elevated cholesterol levels and enhancing their health outcomes.