NewAmsterdam Pharma Company N.V., in partnership with the Menarini Group, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Ubeslo (obicetrapib 10 mg) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination).

The recommendation covers the treatment of adults with primary hypercholesterolaemia, including both heterozygous familial hypercholesterolaemia (HeFH) and non-familial forms, as well as patients with mixed dyslipidaemia, offering a potential new oral treatment option for individuals who remain unable to achieve recommended low-density lipoprotein cholesterol (LDL-C) targets using existing therapies.

The CHMP's positive opinion is based on data from NewAmsterdam Pharma's extensive clinical development programme, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials. The studies demonstrated that obicetrapib monotherapy reduced LDL-C levels by up to 40 percent compared with placebo, while the fixed-dose combination with ezetimibe achieved reductions of approximately 50 percent, with an overall safety and tolerability profile comparable to placebo.

Commenting on the milestone, Michael Davidson, MD, Chief Executive Officer of NewAmsterdam Pharma, said the positive opinion represents an important step forward for patients who continue to face elevated cardiovascular risk despite current lipid-lowering therapies. He noted that the once-daily oral therapy has the potential to address a significant unmet need if approved by the European Commission.

The recommendation will now be reviewed by the European Commission, which is expected to issue a final decision on marketing authorisation later this year. If approved, the medicines will receive a centralised marketing authorisation valid across all European Union member states, as well as Iceland, Liechtenstein and Norway.

Elcin Barker Ergun, Chief Executive Officer of Menarini, welcomed the CHMP recommendation, stating that the company looks forward to making obicetrapib available to patients across Europe who require additional LDL-C lowering beyond currently available treatments.

Under an existing licensing agreement, Menarini holds exclusive commercialisation rights for obicetrapib across Europe and is responsible for regulatory activities and commercial launch in the region. NewAmsterdam Pharma will receive tiered royalties on net sales and remains eligible for additional milestone payments tied to clinical, regulatory and commercial achievements.

Obicetrapib is a novel, low-dose, oral cCholesteryl Ester Transfer Protein (CETP) inhibitor designed to overcome limitations associated with current LDL cholesterol-lowering therapies. Beyond the completed Phase 3 studies, the therapy continues to be evaluated in several ongoing late-stage clinical programmes, including the PREVAIL cardiovascular outcomes trial, as well as the REMBRANDT and RUBENS studies.

The announcement comes as cardiovascular disease continues to be the leading cause of mortality worldwide. Despite the widespread use of statins and other lipid-lowering therapies, many patients remain above recommended LDL-C targets, underscoring the continued need for more effective and well-tolerated treatment options to reduce residual cardiovascular risk.