NewAmsterdam Pharma und die Menarini Group erhalten positive Stellungnahme des CHMP mit der Empfehlung zur Erteilung einer Zulassung für Ubeslo® (Obicetrapib-Monotherapie) und Evlarco® (Festsatzkombination aus Obicetrapib und Ezetimib)
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding the potential approval of Obicetrapib monotherapy and the Obicetrapib/Ezetimib fixed-dose combination in Europe, according to the company.
This recommendation is based on positive data from three Phase 3 studies—BROADWAY, BROOKLYN, and TANDEM—demonstrating statistically significant reductions in low-density lipoprotein cholesterol (LDL-C) of up to 40% with Obicetrapib monotherapy and approximately 50% with the combination therapy, compared to placebo. The decision from the European Commission is expected in the second half of 2026.
Dr. Michael Davidson, Chief Executive Officer of NewAmsterdam, highlighted the significance of the CHMP's opinion, stating it represents a major milestone not only for the company but also for a novel therapy addressing LDL-C and other cardiovascular risk factors. NewAmsterdam aims to meet the unaddressed need of patients who do not achieve their LDL-C target levels with existing therapies.
The positive recommendation will now undergo review by the European Commission, which has the authority to grant centralized approval that would apply across all European Union member states, as well as in Iceland, Liechtenstein, and Norway. Menarini, which holds the exclusive commercialization rights for Obicetrapib in Europe, is responsible for liaising with regulatory authorities and conducting marketing activities throughout the region.
Obicetrapib, developed by NewAmsterdam, is a novel oral drug classified as a CETP inhibitor. It aims to surpass the limitations of current LDL-lowering treatments. Despite the availability of high-dose statins and non-statins, a significant portion of patients continue to struggle in reaching LDL-C target levels, emphasizing the ongoing need for improved therapeutic options.