FDA advisory panel recommends approval of second PCSK9 inhibitor in two days

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An FDA advisory panel on June 10 recommended the approval of evolocumab, a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor intended to reduce low-density lipoprotein cholesterol and improve other lipids.

All 15 members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of evolocumab (Repatha, Amgen) to treat homozygous familial hypercholesterolemia (HoFH). The panel also voted 11-4 in favor of the drug’s approval in one or more patient populations, excluding HoFH.

The four panelists who were not in favor of the approval were:

  • William Hiatt, MD, of the University of Colorado and the Colorado Prevention Center in Aurora, Colorado
  • Abraham Thomas, MD, of NYU Lutheran in Brooklyn, New York
  • Peter Wilson, MD, of Emory University and the Emory Clinical Cardiovascular Research Institute in Atlanta, Georgia
  • Martha Nason, PhD, of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland

On June 9, the panel voted 13-3 in favor of alirocumab, a PCSK9 inhibitor. The FDA is expected to make its decision on alirocumab (Praluent, Regeneron Pharmaceuticals and Sanofi Aventis) by July 24 and on evolocumab by Aug. 27.

There are no PCSK9 inhibitors currently approved in the U.S.

Evolocumab, an injectable medication, has been tested in clinical trials as monotherapy or in combination with other lipid-lowering drugs, including statins. At the FDA advisory panel, Amgen presented data from 10 phase 3 clinical trials that included more than 4,500 patients with high cholesterol.

“It is clear from today’s discussion with the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee that there is a critical need for additional treatment options for patients who are unable to control their high cholesterol despite currently available therapies,” Amgen said in a statement released to Cardiovascular Business. “Elevated LDL-C is recognized as a major risk factor for cardiovascular disease (CVD), and approximately 33 percent of patients at high risk for CVD cannot adequately lower their LDL-C levels with statins and/or other currently approved lipid-lowering therapies.We look forward to continuing to work with the FDA as they complete their review of the Biologics License Application for Repatha TM (evolocumab), in hopes of bringing this important new medicine to patients with high cholesterol.”