The European Commission approved Amgen's PCSK9 inhibitor Repatha (evolocumab) for the treatment of patients with uncontrolled cholesterol who require additional intensive LDL cholesterol reduction, the company announced Tuesday. Specifically, the therapy was cleared for adults with primary hypercholesterolaemia or mixed dyslipidaemia, either alone or in combination with a statin or other lipid-lowering therapies, as well as for the treatment of homozygous familial hypercholesterolaemia (HoFH) in combination with other lipid-lowering therapies in patients aged 12 years and older. Amgen noted that the clearance marks the first time a PCSK9 inhibitor has been approved in the world.
The company said its filing was supported by data from studies involving about 6000 patients with primary hyperlipidaemia and mixed dyslipidaemia, including 10 Phase III trials of more than 4500 patients with high cholesterol. In the clinical studies, Repatha was associated with a significant decrease in LDL cholesterol of about 55 percent to 75 percent versus placebo, and by approximately 35 percent to 45 percent compared to Merck & Co.'s Zetia (ezetimibe). Among patients with HoFH, Repatha lowered LDL cholesterol levels by a significant 15 percent to 30 percent versus placebo, while the effects were maintained with long-term treatment.
Meanwhile, the FDA is expected to issue a final decision on whether to approve Repatha by August 27. An FDA advisory panel backed approval of the drug last month, after similarly recommending approval of Sanofi and Regeneron Pharmaceuticals' PCSK9 inhibitor Praluent (alirocumab). The US regulator is expected to render its decision on Praluent by July 24. For related analysis see, Physician Views Poll Results: How do doctors see Praluent and Repatha stacking up after FDA panel meetings?
Analysts have estimated that Repatha and Praluent could each amass more than $2 billion in annual revenue by 2020. For more insight on the PCSK9 inhibitor market, see ViewPoints: Europe provides positive regulatory momentum for PCSK9 inhibitor class, but regional cardiologists likely to prescribe less than US counterparts. See also Spotlight On: How are PBMs preparing for the impending anti-PCSK9 bonanza? and ViewPoints: Label for newly approved Repatha in EU will have US payers holding their breaths
To read more Top Story articles, click here.