NAARDEN, The Netherlands; MIAMI, USA; and FLORENCE, Italy, July 24, 2026
NewAmsterdam Pharma and its commercialization partner Menarini Group have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for Ubeslo® (obicetrapib 10 mg monotherapy) and Evlarco® (obicetrapib 10 mg plus ezetimibe fixed-dose combination) for the treatment of primary hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), non-familial hypercholesterolemia, and mixed dyslipidemia. The recommendation represents a significant regulatory milestone for the novel oral CETP inhibitor and moves both therapies one step closer to commercialization across the European Union, pending a final decision from the European Commission expected later in 2026. The positive CHMP opinion is supported by robust Phase 3 clinical trial results demonstrating meaningful reductions in low-density lipoprotein cholesterol (LDL-C) among patients who remain above treatment goals despite currently available lipid-lowering therapies.
Phase 3 Program Demonstrates Significant LDL-C Reduction
The CHMP recommendation is based on data from the Phase 3 BROADWAY, BROOKLYN, and TANDEM clinical trials, which evaluated obicetrapib as both a standalone therapy and in combination with ezetimibe. Clinical findings demonstrated that obicetrapib monotherapy reduced LDL-C levels by up to 40% compared with placebo, while the fixed-dose combination with ezetimibe achieved approximately 50% LDL-C reductions, maintaining a safety and tolerability profile comparable to placebo. These encouraging outcomes reinforce obicetrapib’s potential as a once-daily oral therapy for patients whose cholesterol levels remain inadequately controlled despite statins or other lipid-lowering treatments. Development of the medicine continues through additional late-stage studies, including the PREVAIL cardiovascular outcomes trial, as well as the ongoing REMBRANDT and RUBENS Phase 3 programs designed to further evaluate long-term cardiovascular benefits and clinical performance.
Potential New Option for Patients with High Cardiovascular Risk
Cardiovascular disease remains the leading cause of death worldwide, and many patients continue to experience elevated LDL-C despite the widespread availability of statins and other lipid-lowering medicines. According to NewAmsterdam Pharma, millions of individuals remain untreated or fail to achieve recommended LDL-C targets, contributing to persistent cardiovascular risk and highlighting the need for innovative therapeutic approaches. Obicetrapib, a low-dose oral CETP inhibitor, has been specifically developed to address this treatment gap by offering an effective, convenient, once-daily therapy that can be used alongside existing cholesterol-lowering medications. If approved, both Ubeslo® and Evlarco® could provide clinicians with additional treatment options for patients requiring further LDL-C reduction while supporting broader efforts to reduce cardiovascular events through improved lipid management.
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European Commercialization Moves Closer Following CHMP Opinion
Following the positive CHMP recommendation, the application will now undergo review by the European Commission, which has the authority to grant centralized marketing authorization across all European Union Member States, as well as Iceland, Liechtenstein, and Norway. Under the companies’ licensing agreement, Menarini Group holds exclusive commercialization rights for obicetrapib throughout Europe and will oversee regulatory activities and market launch following approval. The agreement also positions NewAmsterdam Pharma to receive tiered royalties and potential milestone payments tied to future regulatory, clinical, and commercial achievements. The positive CHMP opinion marks a major step toward bringing a novel LDL-C lowering therapy to patients across Europe and strengthens both companies’ commitment to advancing innovative cardiovascular medicines that address significant unmet medical needs.
Source: NewAmsterdam Pharma, Menarini Group press release
