Amgen Inc. announced on Thursday that it will seek U.S. government approval to sell a pipeline drug that has significantly reduced cholesterol for patients in Phase III studies.
The Thousand Oaks biopharmaceutical company said it will submit a biologics license application to the Food and Drug Administration for evolocumab, which has been administered to about 6,800 patients in trial studies.
Amgen also released results of a recent study in Japan that showed evolocumab injections in combination with statins, a long-established class of oral drugs for cholesterol control, resulted in a statistically significant reduction of LDL-C, or so-called “bad” cholesterol.
“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,” said Dr. Sean Harper, executive vice president of research and development at Amgen, who called the FDA application a “milestone” in the drug’s development process.
Evolocumab would be the first in a new class of biologically produced drugs that promise to reduce cholesterol. However, French biotech giant Sanofi and partner company Regeneron are working on a competing drug called alirocumab.
In a note to investors, Matthew Rhoden, an analyst at UBS, said Amgen’s announcement came sooner than expected.
“If first to market, Amgen would be in the position to set the price and establish a nominal first mover advantage (although we expect Regeneron/Sanaofi’s alirocumab to be a fast follower),” he wrote.
Amgen shares closed up 86 cents, or less than 1 percent, to $138.69 on the Nasdaq.