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FDA to Complete Review Of Amgen's Prolia In July

From Associated Press (February 22, 2010)

NEW YORK -- The Food and Drug Administration will take about five more months to complete a review of Amgen Inc.’s bone drug Prolia , keeping the biotechnology company’s potential blockbuster off the market until the end of July.

Late Friday, Amgen said the FDA will complete a review of Prolia by July 25. The Thousand Oaks, Calif., company is seeking approval to market Prolia as a treatment for osteoporosis caused by menopause, and is also hoping to market Prolia to prevent or treat bone loss in patients with breast or prostate cancer.

Prolia has not been approved for sale. Amgen asked for approval in both indications in late 2009. The FDA wanted more information about the drug as a treatment for postmenopausal osteoporosis. Amgen submitted that data in January. The FDA decided Friday that the new data was a class II resubmission, which is typically reviewed in six months. A class I submission is usually reviewed in about two months.

Class II resubmissions generally have more information in them than class I filings.

Analysts think Prolia should bring Amgen billions in revenue after it is approved. Sales of the company’s former top sellers, the anemia drugs Aranesp and Epogen, have dropped in recent years due to safety concerns and label restrictions.

Robert W. Baird and Co. analyst Christopher Raymond said he was hoping for a class I designation, and he reduced his revenue estimates for Amgen because of the delay. Raymond he said he still expects Prolia to be approved and reach the market later this year.

Other analysts, including Eun Yang of Jefferies and Co., said they expected a six-month review. Amgen is preparing to submit new data on Prolia as a treatment for bone loss in cancer patients.

In morning trading, Amgen shares slipped fell 37 cents to $57.01.

Posted: February 2010


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