Once approved, how will denosumab fare against Zometa and other bone-strengthening drugs on the market?
Early signs look good. At the recent San Antonio Breast Cancer Symposium, a study of denosumab's impact on bone strength showed it cut the rate of fractures and other bone complications in patients with breast cancer better than Zometa and had fewer side effects.
Amgen says it expects to release data from a similar study on building bone strength by the end of March. Click here to read more.
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Amgen said last Friday that that the US FDA has evaluated the company's Complete Response submission for Prolia (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission.
With the Class 2 designation, the agency set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.
In October 2009, the FDA's Division of Reproductive and Urologic Products issued a Complete Response letter for the Biologic License Application (BLA) for Prolia in the treatment and prevention of postmenopausal osteoporosis.
The letter requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. The letter did not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA also requested all updated safety data related to Prolia. Amgen said it submitted the requested information for the treatment indication in late January 2010.
The company added that it continues to work with the FDA to determine appropriate next steps regarding its indications for Prolia in the prevention of postmenopausal osteoporosis, as well as in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.
4/27: This week, Amgen said it is hoping to regain sales momentum with its osteoporosis drug Prolia, which is currently being reviewed by the Food and Drug Administration.
The FDA is scheduled to make a decision on Prolia by July 25. Wall Street sees Prolia as a potential billion-seller that could recharge Amgen's revenue growth.
5/19: Amgen said last Friday it filed a new marketing application for its drug candidate denosumab, asking regulators to approve it as a treatment for bone damage suffered by cancer patients.
Amgen is asking the FDA to approve denosumab to prevent or treat damage caused by tumors that spread to the skeleton, or bone metastases.
When tumors spread to the bone, the bones become weaker, which can cause fractures and compression that require surgery or radiation therapy.
Amgen said bone metastases occur in about 1.5 million cancer patients per year, most often in people with prostate, lung or breast cancer.
Amgen said it will also apply for approval in the European Union, Switzerland, Canada, Australian and Japan. In Japan, Amgen is partnering with drug maker Daichii Sankyo.
Denosumab is seen as a possible blockbuster that could recharge the biotechnology company’s revenue growth. In August, Amgen asked the FDA to approve the drug as a treatment for osteoporosis caused by menopause. The agency is scheduled to make a decision on that application by July 25. If the drug is approved, Amgen will sell it under the name Prolia.
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