FDA Accepts Application for Amgen Bone Loss Drug

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Amgen Inc. said Wednesday the U.S. Food and Drug Administration has accepted its application for the bone-loss drug denosumab, which Wall Street believes has the potential to become another billion-dollar blockbuster product for the company.

The Thousand Oaks biotech said it expects the FDA agency to make a ruling by Oct. 19. Amgen submitted its application in December.

Amgen wants to market the drug to both treat postmenopausal osteoporosis and prevent bone loss in patients being treated for prostate cancer or breast cancer. The drug is the first fully human monoclonal antibody in late stage clinical development that specifically targets a certain essential regulator of the cells that break down bone. Monoclonal antibodies are proteins employed by the immune system to attack what it considers foreign substances, and in early treatments were synthesized from non-human cells.

Amgen also has applications pending in the European Union, Canada, Switzerland and Australia. With Amgen’s flagship anemia franchise significantly hurt by safety concerns, analysts consider denosumab critical to the company’s growth prospects.

Amgen shares closed up 98 cents, or 1.7 percent, $57.39 on the Nasdaq.

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