The EMA’s CHMP has recommended marketing authorisation for two obicetrapib treatments for adults with primary hypercholesterolaemia and mixed dyslipidaemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for two obicetrapib-based treatments developed by NewAmsterdam Pharma and its European partner Menarini Group.

The positive opinion covers Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination) for adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH), and non-familial or mixed dyslipidaemia.

The European Commission is expected to make a final decision on marketing authorisation in the second half of 2026.

The CHMP recommendation is supported by data from the Phase 3 BROADWAY, BROOKLYN and TANDEM trials.

Across the clinical programme, obicetrapib monotherapy demonstrated statistically significant reductions in low-density lipoprotein cholesterol (LDL-C) of up to 40% compared with placebo. The combination of obicetrapib and ezetimibe produced LDL-C reductions of approximately 50% compared with placebo.

The company said the treatments had a tolerability profile comparable to placebo in the Phase 3 studies.

Michael Davidson, chief executive officer of NewAmsterdam Pharma, said: “Today’s positive CHMP opinion is a significant milestone—not just for NewAmsterdam but for a novel therapy, addressing LDL-C and other drivers of residual cardiovascular risk.”

Obicetrapib is an oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor being developed as a treatment for patients who remain above their LDL-C targets despite existing lipid-lowering therapies or who cannot tolerate current treatments.

Cardiovascular disease remains a leading cause of death globally, while many patients at increased cardiovascular risk do not reach recommended LDL-C targets despite available lipid-lowering treatments.

The potential treatments are intended for patients with primary hypercholesterolaemia, including people with heterozygous familial hypercholesterolaemia, as well as those with non-familial or mixed dyslipidaemia.

The CHMP recommendation follows a broader clinical development programme that has evaluated obicetrapib both as a monotherapy and in combination with ezetimibe.

The Phase 3 PREVAIL cardiovascular outcomes trial is also evaluating whether obicetrapib can reduce major adverse cardiovascular events. The trial has enrolled more than 9,500 patients, with further Phase 3 studies including REMBRANDT and RUBENS also ongoing.

Elcin Barker Ergun, chief executive officer of Menarini, said: “Pending a positive European Commission decision, we look forward to helping bring obicetrapib, an oral pill with a unique mechanism of action, to patients across Europe to help reach their LDL-C targets that they could not reach with existing treatments.”

The European Commission will now review the CHMP opinion and decide whether to grant centralised marketing authorisation. If approved, the authorisation would apply across European Union member states, as well as Iceland, Liechtenstein and Norway.

Menarini holds exclusive commercialisation rights for obicetrapib in Europe under its agreement with NewAmsterdam Pharma.

The potential European approval of both obicetrapib monotherapy and the fixed-dose combination with ezetimibe would provide additional oral treatment options for patients who are unable to reach recommended LDL-C targets with existing therapies.