NewAmsterdam Pharma et le groupe Menarini reçoivent un avis favorable du CHMP recommandant l'autorisation de mise sur le marché d'Ubeslo® (obicetrapib en monothérapie) et d'Evlarco® (association à dose fixe d'obicetrapib et d'ézétimibe)
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization for Ubeslo® (obicetrapib 10 mg as monotherapy) and Evlarco® (the fixed-dose combination of 10 mg obicetrapib and 10 mg ezetimibe) for patients with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH) and non-familial or mixed dyslipidemia, according to the company. The decision from the European Commission is anticipated in the second half of 2026.
NewAmsterdam Pharma Company N.V., a biopharmaceutical company focused on developing oral, non-statin drugs for patients at risk of cardiovascular disease, has stated that the CHMP's recommendation is based on positive results from the phase III clinical trials BROADWAY, BROOKLYN, and TANDEM. These studies demonstrated statistically significant reductions in LDL cholesterol levels of up to 40% with obicetrapib monotherapy compared to placebo, and approximately 50% with the combination of obicetrapib and ezetimibe.
Dr. Michael Davidson, CEO of NewAmsterdam, noted that the favorable opinion marks a significant milestone, expressing gratitude for the ongoing collaboration with Menarini, the company’s partner in this endeavor. He added that if approved, obicetrapib could address a major unmet need for patients who do not achieve their LDL-C targets with existing treatments.
The CHMP’s recommendation will be reviewed by the European Commission, which holds the authority to grant a centralized market authorization valid across all European Union member states, as well as in Iceland, Liechtenstein, and Norway. Menarini, which holds exclusive marketing rights for obicetrapib in Europe, is responsible for regulatory and commercialization efforts in the region.
NewAmsterdam is entitled to tiered royalties and potential milestone payments of up to €833 million under the licensing agreement with Menarini, contingent on achieving various clinical, regulatory, and commercial milestones. The company aims to provide effective and well-tolerated treatment options that can significantly reduce LDL-C levels in patients unable to meet their targets with current therapies.