CHMP Recommends Marketing Authorization for New Cardiovascular Drugs
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for two new drugs targeting cardiovascular disease in Europe.
New Drugs for Cardiovascular Disease Receive Positive CHMP Recommendation in Europe
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the marketing authorization of Ubeslo® (obicetrapib) and Evlarco® (obicetrapib and ezetimibe fixed-dose combination). These drugs are intended for patients with elevated low-density lipoprotein cholesterol (LDL-C) who do not adequately respond to or tolerate existing therapies.
The positive recommendation is based on data from Phase 3 clinical trials, including BROADWAY, BROOKLYN, and TANDEM. These studies demonstrated statistically significant reductions in LDL-C. Obicetrapib as monotherapy reduced levels by up to 40% compared to placebo, while the combination with ezetimibe achieved approximately 50% reduction. The tolerability profile was found to be comparable to placebo.
NewAmsterdam Pharma, in partnership with Menarini Group, is developing the drugs. Following the CHMP's recommendation, the European Commission is expected to make a final decision on marketing authorization in the second half of 2026. Menarini Group will be responsible for the commercialization of obicetrapib in Europe.
Cardiovascular disease remains a leading cause of death globally. The need for novel treatments is significant, particularly for patients with high LDL-C levels who face an increased risk of heart attack and stroke despite current therapies.