NewAmsterdam Pharma receives first global approval for obicetrapib cholesterol drugs

• NewAmsterdam Pharma (NASDAQ:NAMS) and Menarini received European Commission marketing authorization for Ubeslo and Evlarco.
• The approvals mark the first global regulatory approval for obicetrapib-based therapies.
• Phase 3 trials showed significant LDL cholesterol reductions with both monotherapy and combination treatment.

NewAmsterdam Pharma (NASDAQ:NAMS) and partner Menarini Group announced that the European Commission has granted marketing authorization for Ubeslo® (10 mg obicetrapib monotherapy) and Evlarco® (10 mg obicetrapib plus 10 mg ezetimibe).

The approvals represent the first global regulatory authorization for obicetrapib and cover treatment of adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, and mixed dyslipidaemia.

The approvals were supported by results from the Phase 3 BROADWAY, BROOKLYN and TANDEM clinical trials.

In these studies, obicetrapib monotherapy demonstrated statistically significant LDL cholesterol reductions of up to 40% compared with placebo, while the fixed-dose combination of obicetrapib and ezetimibe achieved approximately 50% LDL-C reductions compared with placebo.

The companies reported that tolerability was comparable to placebo across the trials.

Under an exclusive European licensing agreement, Menarini will oversee regulatory and commercial activities for the products in Europe.

NewAmsterdam Pharma is eligible to receive tiered double-digit royalties on European net sales and up to an additional €833 million in potential clinical, regulatory and commercial milestone payments.

The company continues to evaluate obicetrapib in additional Phase 3 programs, including the PREVAIL cardiovascular outcomes trial, which has enrolled more than 9,500 patients.