EU Nod Grants Amgen’s Repatha Edge Over Rival Praluent

July 27, 2015

Regulators in the EU have cleared the way for Amgen to market its cholesterol-lowering drug Repatha, marking the world’s first approval of a PCSK9 inhibitor.

The approval gives Repatha (evolucumab) a clear marketing advantage over Sanofi and Regeneron’s Praluent (alirocumab), which is awaiting consideration by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Both drugs have shown strong results in reducing low-density lipoprotein — or bad — cholesterol, with few side effects.

Final approval by the European Commission could take up to another two months, as was the case with Repatha, which was recommended in late May.

In June, the FDA’s Endocrinological and Metabolic Drugs Advisory Committee voted 11-4 to recommend Repatha as a treatment for patients with high cholesterol and a high risk of cardiovascular events. The panel also recommended Praluent for patients with high LDL-C, but said more data was needed to support the drug’s effects on cardiac outcomes.

Amgen says Repatha will be available in some member states as early as the next few weeks. — Jonathon Shacat