Experimental Osteoporosis Drug Dogged by Infection, Cancer Concerns

An experimental drug Amgen Inc. is working on for treatment of osteoporosis in women past menopause and other therapies is facing increasing questions about the increased risks of cancers and serious infections.

The drug company has asked the Food and Drug Administration to approve denosumab, which would be marketed under the brand name Prolia. The drug could be a billion-dollar blockbuster for Amgen if approved to treat osteoporosis in some women and to prevent and treat bone loss caused by hormone ablation therapy for prostate and breast cancer patients.

The FDA, however, is citing questions about side effects from the drug, which could throw a wrench in Amgen’s plans to unveil the drug sometime in 2010, according to documents detailed in a Reuters Health report.

“Of particular concern, in light of these safety issues, is whether the risk/benefit balance for the osteoporosis prevention indication, both for patients with and without cancer, supports approval,” FDA reviewers said in a memo prepared for an advisory panel review on Thursday.

An advisory panel of medical experts is expected to consider the risks and benefits of the drug and recommend whether the FDA should approve denosumab. While the FDA is not required to follow the advice of its advisory panels, most of the time, it does.

Drug-industry watchers dubbed the FDA’s side effect concerns “not surprising” and said it has been known that drug regulators likely will require Amgen to develop a strict risk-management plan for the drug if it is approved.

Stay tuned later this week for word on whether the advisory panel recommends approval for Prolia.

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