Prolia and Fracture Risk Reduction

FDA approves denosumab for postmenopausal women at increased risk of fractures.
The Wall Street Journal (6/2, Gryta) reports that the Food and Drug Administration has approved Amgen's Prolia (denosumab) for postmenopausal women who face an increased risk of fractures.
The Los Angeles Times (6/2, Olivarez-Giles) reports that the drug, "which has been in development for about 15 years, will be available to the public within the next week, Amgen said in a statement."
The AP (6/2, Perrone) reports that "pill-based osteoporosis drugs, such as Fosamax [alendronate] and Zometa [zoledronic acid], have been available for more than a decade." However, "Amgen Executive Vice President Dr. Roger Perlmutter said many women can't tolerate those drugs or have trouble remembering to take a daily medication." The drugmaker "said in a statement that Prolia is the first drug to target a cellular pathway that breaks down bones."
Bloomberg News (6/2, Waters) reports that "Amgen will follow more than 4,500 women who started taking denosumab in clinical trials for up to 10 years and will create a monitoring program to solicit reports and compile records about any adverse events in women taking the drug, the company said in a statement." The drugmaker "asked the FDA in a separate application to approve denosumab for reducing fractures in cancer patients whose tumors have spread to their bones." Amgen is also "conducting studies to see if the drug can stop cancer from spreading to bone."
The Ventura County Star (6/2, Hoops) notes that "the FDA's approval is ahead of schedule -- the target date was July 25 -- but comes on the heels of the European Union's granting of marketing authorization, which came Friday." Reuters (6/2, Berkrot) also covers the story.