Amgen submitted an application to the FDA seeking approval of the PCSK9 inhibitor evolocumab for the treatment of high cholesterol, the company reported Thursday. Sean E. Harper, executive vice president of R&D at Amgen, noted that the filing "marks the first of several submissions to regulatory authorities around the world for our lipid-lowering programme."
The application, which Amgen said is the first made to the FDA for a PCSK9 inhibitor, is supported by data from approximately 6800 patients, including more than 4500 subjects with high cholesterol in 10 Phase III trials. The late-stage studies, which included the RUTHERFORD-2, LAPLACE-2 and GAUSS-2 trials, assessed the safety and efficacy of evolocumab in patients with elevated cholesterol on statins with or without other lipid-lowering therapies, patients intolerant to statins and patients with heterozygous familial hypercholesterolaemia or homozygous familial hypercholesterolaemia.
"We look forward to working closely with regulatory authorities to bring this new treatment option to patients with high cholesterol who, despite currently available therapies, are unable to adequately reduce their LDL cholesterol levels," added Harper. Last month, Amgen announced a restructuring plan including staff reductions of up to 2900 positions as it looks to reallocate resources to invest in upcoming launches and drive growth (for related analysis, see ViewPoints: Amgen puts its money where its mouth is in backing its next wave of new launches and ViewPoints: Amgen takes an important step towards opening its cardiovascular account).
Other drugmakers developing PCSK9 inhibitors include Pfizer and a collaboration between Regeneron Pharmaceuticals and Sanofi. In July, Sanofi and Regeneron disclosed plans to submit alirocumab for approval in the US and EU by the end of the year after study results showed that the therapy significantly reduced LDL cholesterol levels versus placebo or active comparator in patients with hypercholesterolaemia. The companies also revealed the purchase of an FDA priority review voucher from BioMarin Pharmaceuticals for $67.5 million, which they indicated will be used to speed the agency's assessment of the PCSK9 inhibitor (for further analysis, read ViewPoints: But what is an FDA priority review voucher actually worth? BioMarin finally puts a price tag on it).
For related analysis on PCSK9 inhibitors, see Physician Views Poll Results: Lack of outcomes data, negative IMPROVE-IT results will limit PCSK9 inhibitor use; less frequent dosing seen as offering minimal advantage.
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