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FDA accepts BLA for evolocumab as LDL-lowering therapy

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Amgen announced that the FDA has accepted the company’s Biologics License Application for the use of its PCSK9 inhibitor evolocumab to treat elevated LDL.

According to a press release from the company, the application follows results from studies incorporating approximately 6,800 patients, including 4,500 participants with elevated cholesterol across 10 phase 3 trials under the PROFICIO program. These trials assessed evolocumab in patients receiving statins with or without additional lipid-lowering medications; statin-intolerant participants; and patients with heterozygous or homozygous familial hypercholesterolemia.

PROFICIO will include a total of 22 trials, with a planned combined enrollment of 35,000 patients. In addition to the already published DESCARTES trial, which assessed evolocumab in patients with hyperlipidemia and risk for CVD, long-term safety and efficacy data will be evaluated in five ongoing phase 3 trials, according to the release:

• FOURIER, evaluating combination therapy with statins and either evolocumab or placebo for the reduction of CV events in a cohort of 27,500 patients with CVD
• EBBINGHAUS, an analysis of cognitive function in a subset of FOURIER participants
• OSLER-2, an open-label study incorporating patients who completed other phase 3 trials from the PROFICIO program
• GLAGOV, assessing the impact of evolocumab on coronary atherosclerosis among cardiac catheterization recipients
• TAUSSIG, evaluating the safety and efficacy of evolocumab as an LDL-lowering therapy in patients with severe familial hypercholesterolemia.

Sean E. Harper

“There is still a large unmet need among patients with high CV risk and elevated cholesterol who are unable to reach optimal LDL cholesterol levels with current therapies,” Sean E. Harper, MD, executive vice president of research and development at the company, said in the release. “Evolocumab has the potential to provide significant additional benefit when added to existing LDL cholesterol-lowering medications for patients with high cholesterol.”

According to the release, the FDA has set a target action date of Aug. 27, 2015 under the Prescription Drug User Fee Act for the application.