BRIEF-US FDA advisory panel backs Amgen drug for osteoporosis. Date: August13,2009 Time:2:57 PM WASHINGTON, Aug 13 (Reuters) - A U.S. Food and Drug Administration advisory committee:
* Backs Amgen Inc's <AMGN.O> denosumab to treat post-menopausal women with osteoporosis.
* Votes unanimously, 15-0, that denosumab benefits outweigh any risks for treating osteoporosis.
* Continues its meeting to consider other issues related to denosumab.
((Reporting by Lisa Richwine and Julie Vorman; Company news desk in Washington; +1 202 898 8400, firstname.lastname@example.org)) ________________________________
BRIEF-FDA panel also backs Amgen drug to treat bone loss in prostate cancer patients. Date:August 13, 2009 Time: 4:15 PM WASHINGTON, Aug 13 (Reuters) - A U.S. Food and Drug Administration advisory committee:
* Backs Amgen Inc's <AMGN.O> denosumab to treat bone loss from hormone ablation therapy in patients with prostate cancer.
* Votes, 9-4, that denosumab has favorable risk/benefit ratio for treating bone loss from prostate cancer therapy; 1 panelist abstained.
* Earlier, the committee unanimously voted to back the use of denosumab to treat osteoporosis in post-menopausal women with the disease. However, the panel also voted to reject the drug's use as a treatment to prevent osteoporosis in women, or to treat or prevent bone loss in breast cancer patients.
_________________________________________ These are the facts from the FDA's review. The third * is the key: the FDA has to extend (probably beyond this week!) its decision regarding approval to market "to consider other issues related to denosumab." There seems to be some concern that there is an increased risk of infections or an impact on the immune system.
These concerns and further deliberations are not BAD news, they reflect the basic hesitation inherent in FDA deliberations that doctors prescribing denosumab be alerted to the possible negative outcomes. These risks have to be noted in the RX literature.
So we have acknowledgment of denosumab's value, but a (short?) delay in outright approval, pending wording on the RX lit, which will probably be provided by Amgen itself, since the data on which FDA based its reservations was provided by Amgen.
Backs osteoporosis benefits. Backs prostate cancer benefits. Both -> Benefits>risks. Short delay. Approval imminent.
There's NO BAD NEWS HERE !
The share price drop below $62 late in today's session gives traders a great opportunity to get in, and make $5.00 or more in a very short time on AMGN.