Amgen became the first drugmaker to seek U.S. regulatory approval for a new class of cholesterol-lowering treatments after it submitted an application to the Food and Drug Administration on Thursday for evolocumab.
Thousand Oaks-based Amgen said the drug works by blocking a naturally occurring protein called PCSK9 that prevents the liver from removing LDL cholesterol, so-called “bad” cholesterol, from the bloodstream. Evolocumab will be aimed at patients who cannot use statins such as Lipitor, made by rival Pfizer, or for whom existing cholesterol treatments aren’t effective, it said.
“This [biologics license application] submission to the FDA marks the first of several submissions to regulatory authorities around the world for our lipid-lowering program and represents a critical milestone in our overall global development program for evolocumab,” Sean Harper, executive vice president of research and development at Amgen, said in a news 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.”
New York-based Regeneron and its Paris-based partner, Sanofi, are also working to bring a competing treatment, alirocumab, to market. The two firms have secured a special voucher that allows them to expedite the regulatory approval process for the drug from the standard 10-month timeframe to six, according to Reuters. Analysts have predicted that if effective at preventing heart attacks, PCSK9 inhibitors could open up a new multibillion-dollar market, the news agency said.
Amgen, the largest private-sector employer in the Tri-Counties, last month announced plans to lay off between 2,400 and 2,900 people mostly in the U.S., including at its Thousand Oaks headquarters. The company said it was cutting jobs across its business lines and shutting research and development operations in Colorado and Washington so that it can focus on shepherding 10 late-stage molecules to market.
[Correction, Aug. 25, 2014: This story originally misstated where Amgen's recently announced job cuts would occur and what parts of the company they would affect.]