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Amgen files BLA for evolocumab to treat high cholesterol

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Amgen announced that it has submitted a Biologics License Application to the FDA for its PCSK9 inhibitor evolocumab, seeking approval for the treatment of high cholesterol.

The application is the first BLA submitted for a PCSK9 inhibitor, according to an Amgen press release.

The application for evolocumab, an investigational fully human monoclonal antibody, contains data from approximately 6,800 patients, 4,500 of which participated in 10 phase 3 trials of patients with high cholesterol, according to the release.

The phase 3 studies evaluated the safety and efficacy of evolocumab in patients who had elevated cholesterol despite statin therapy and who were or were not using other lipid-lowering therapies, statin-intolerant patients, patients with heterozygous familial hypercholesterolemia and patients with homozygous familial hypercholesterolemia, according to the release.

“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,” Sean E. Harper, MD, Amgen’s executive vice president of research and development, said in the press release.

Amgen also announced that the phase 3 YUKAWA-2 study of evolocumab in combination with statin therapy in Japanese patients with high cholesterol and CV risk met both of its primary endpoints. The study included 404 patients, all of whom were taking atorvastatin.

Compared with those assigned placebo, patients assigned evolocumab achieved a significant percent reduction from baseline LDL at 12 weeks and a significant mean percent reduction from baseline LDL at 10 weeks and 12 weeks, according to an Amgen press release. Safety issues were balanced across groups. The most common adverse events in the evolocumab group were nasopharyngitis, gastroenteritis and pharyngitis.

The full results of the YUKAWA-2 study will be submitted for presentation at a future medical conference and for publication, according to the release.