An FDA advisory committee voted 11-4 on Wednesday recommending clearance of Amgen's cholesterol-lowering drug Repatha (evolocumab). In addition, the panel voted 15-0 in favour of backing approval of the therapy for patients with homozygous familial hypercholesterolaemia. Earlier this week, an agency advisory panel backed approval of Sanofi and Regeneron Pharmaceuticals' PCSK9 inhibitor Praluent (alirocumab).
In briefing documents released ahead of the panel meeting, FDA reviewers agreed that Repatha can significantly lower LDL cholesterol levels but questioned whether the drug should be approved for certain patient groups. Study data published earlier this year in the NEJM indicated that both Repatha and Praluent can significantly reduce LDL cholesterol levels and reduce the risk of adverse cardiovascular events.
Meanwhile, some panellists expressed concerns that the application for Repatha, as well as Praluent, was primarily based on its effects on LDL cholesterol opposed to cardiovascular outcomes. "It would be important to have clinical evidence of benefit, and a surrogate is not adequate," said committee member William R. Hiatt. Conversely, panellist Philip Sager stated that he supported clearance of Repatha "because of the large, unmet medical need."
Amgen has completed enrolment in a 27 500-patient study seeking to clarify whether the effects of Repatha on LDL cholesterol levels translate into cardiovascular benefits, with results from the trial expected in 2017. Sanofi and Regeneron have initiated a similar study of Praluent, with data anticipated within the same time frame.
The FDA is expected to issue a final decision on whether to approve Repatha by August 27. Meanwhile, a decision on Praluent, which was granted priority review by the FDA after Sanofi and Regeneron purchased a priority review voucher from BioMarin Pharmaceuticals last year for $67.5 million, is anticipated by July 24.
For related analysis on the PCSK9 inhibitor class, see ViewPoints: Has the Praluent AdCom vote blown the PCSK9 inhibitor market wide open?. See also .
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