Amgen osteoporosis drug Approved by FDA

Posted by SwatiR on Jun 02, 2010 | Leave a Comment

The U.S. Food and Drug Administration have approved the Amgen’s osteoporosis drug on Tuesday, 1st June. Previously, the drug has received European approval last week. Amgen’s osteoporosis drug, Prolia is prepared to help prevent fractures in postmenopausal women. It is an injectable treatment for postmenopausal women who are at high risk for fractures due to osteoporosis.

FDA Approved Amgen osteoporosis drug

Amgen Manufacturing Limited is a subsidiary of Thousand Oaks, California-based Amgen Inc. Prolia, Amgen’s osteoporosis drug is chemically known as denosumab. The agency has expected action date of July 25 for prolia but FDA approved this drug nearly two months ahead. Now, this drug is widely considered to be Amgen’s most important future growth driver. Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein.


In Osteoporosis, bones become too weak and are more likely to break. In the United States, 80% of the people with osteoporosis are women according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Drug, prolia is recommended once every six months. It is given by injection and it works to reduce the destruction of bone and raise bone mass and strength by inhibiting proteins that activate bone-destroying cells. Prolia will be available in the market at the cost of $825 per 60 mg injection.

Dr. Julie Beitz, director of an F.D.A. office of drug evaluation said in a statement, “Due to its prevalence, osteoporosis is a serious concern to public health. The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.” Prolia has decreased the incidence of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis in one pivotal study and it was the basis for the approval of the drug.

The good news was greeted by investors as they sent Amgen shares more than 3 percent higher in after-hours trading. According to Thomson Reuters, the estimation of analysts shows that the product could see annual global sales of $3.3 billion in 2014 for the world’s biggest biotechnology company. Shares of Amgen rose to $52.50 in extended trading from their Nasdaq and close at $50.76.

The FDA said that “Because drugs that work the way Prolia does increase the risk of developing osteonecrosis of the jaw, a severe bone disease, the approval comes with a risk evaluation and mitigation strategy (REMS) that includes a medication guide for patients and information for healthcare providers that explains the risks and benefits of the drug”.

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