FDA: Amgen Osteoporosis Drug Could Affect Immune System
12 August 2009 - 2:56AM
Dow Jones News
The Food and Drug Administration said a proposed new type of
osteoporosis drug from Amgen Inc. (AMGN) was effective at
increasing bone mineral density and reducing the risk of fractures
but could increase the risk of serious infections.
The FDA said it was concerned denosumab "has the potential to
affect multiple layers of the immune system," which could result in
the development of serious infections and cancer. In order to treat
or prevent osteoporosis, denosumab is designed to inhibit a protein
known as RANK Ligand that's involved with bone destruction.
However, the same protein also plays a role in the body's immune
system.
The agency said clinical trials involving denosumab showed a
slightly higher rate of serious infections and the development of
certain types of cancer. The agency also said there's a "potential
for tumor progression in patients with cancer."
The drug, denosumab, faces a review Thursday by an outside panel
of medical experts, and the FDA posted a review of the product on
its Web site Tuesday.
Amgen is seeking FDA approval for denosumab to treat or prevent
osteoporosis in postmenopausal women and bone loss caused by
hormone treatment in patients with breast or prostate cancer. The
company said denosumab has a "favorable benefit-risk profile in the
indications sought."
The FDA said it would ask the panel "whether the risk/benefit
balance for the osteoporosis prevention indication, both for
patients with and without cancer, supports approval." The outcome
of that and other expected votes on the product will amount to a
recommendation about whether denosumab should be a approved.
The FDA usually follows its panel's advice but isn't required
to. The agency is expected to make a final decision whether to
approve denosumab by about Oct. 19. If approved the drug would be
sold under the brand name Prolia.
Denosumab is the first type of drug in its class and acts in a
different manner than many other drugs like Boniva, Fosamax,
Reclast and Zometa that are considered bisphosphonates in order to
prevent bone loss. Denosumab would be injected twice a year.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com