This breaking news is excerpted from an article by Val Brickates Kennedy, MarketWatch, last updated 10:20 AM ET Oct 19, 2009
"The Food and Drug Administration has declined to approve its (Amgen's) new osteoporosis drug denosumab, or Prolia, until the company provides more supporting information for its application."
"Amgen said early Monday that the FDA has informed the biotech firm that it will need more supporting information before it can approve Prolia for the treatment of post-menopausal osteoporosis. Amgen added that the agency is not, however, requiring the company to run any additional clinical trials."
"The company also said it expects to receive a separate response from the FDA regarding its application to market Prolia for the prevention of bone loss in certain breast- and prostate-cancer patients."
"Many investors and analysts have viewed Prolia's approval as key to Amgen's future growth."
Already a member? Sign in
Welcome to Inspire!
What - Inspire is a place where you can connect with people who share your health concerns and find information and advice in groups sponsored by organizations you know and trust.
Why - As a member you can use Inspire to let friends and family know how you're doing, contact others who share your health concerns, receive personalized updates and information about participating in surveys and clinical trials, and more.
How - Joining Inspire is completely free and usually takes less than a minute. Join now!
FDA Declines Denosumab Approval
- By BoneLady
- Posted October 19, 2009 at 10:40 am · 13 replies
- In Osteoporosis medications
- Shared with the public
Explore topics in this discussion:
Cancer Actonel Forteo Osteoporosis Alendronate Psoriasis Reclast
13 replies
- Oldest first
- Newest first
- By millie123
- Posted October 19, 2009 at 10:48 am
- Report post
Wow! I thought one of our members was already signed up for future trials. Who was that?
- By BoneLady
- Posted October 19, 2009 at 12:23 pm
- Report post
millie123,
Some NOF members have expressed interest in following the progress of this new drug. I don't know of someone planning to participate in a clinical trial. Although delayed, FDA approval for post-menopausal osteoporosis may still be granted after the FDA gets more supporting information from Amgen.
- By Gemstone36
- Posted October 19, 2009 at 12:27 pm
- Report post
Since I have decided not to go onto Reclast, I was hoping Denosumab would be approved this month so we could get a few months of public use before I try it. Oh well, more patience builds character, I guess, but not bones. Jim
- By Char42
- Posted October 19, 2009 at 2:48 pm
- Report post
Hey you can get the Bisphosphonate toxins on the medical market to lessen your quality of life.
Alas still waiting to be a denosumab guinea pig.
http://www.fiercebiotech.com/press-releases/amgen-provides-update-status-pr olia-tm-denosumab-biologics-license-application-bla-su
- By drizzit
- Posted October 19, 2009 at 9:01 pm
- Report post
Not a huge surprise. The FDA did the same thing for another new drug called Stelara for psoriasis. Seems that anytime we have a drug that is totally new in how it works the FDA is requiring a post launch program for monitoring patients. I suspect that is what the company will have to spell out before the get the OK.
It took Stelara about an extra 9 months to get approved but it is now on the market. Look for the same here.
The key here is that the FDA did not require any new trials. They want more info but are content with the current safety in the trials that were run.
my take anyway based on what the FDA has been doing lately. Probably a good thing in the long run.
- By BoneLady
- Posted October 20, 2009 at 11:56 am
- Report post
Gemstone36 and drizzit,
Thank you for your comments. Waiting can be rough, but it is good to see the FDA taking precautions with an osteoporosis drug in a new category.
- By BoneLady
- Posted October 20, 2009 at 11:58 am
- Report post
Char42,
Thanks for the link. It provides more details about what the FDA is requiring from Amgen.
- By Raven1
- Posted October 20, 2009 at 6:16 pm
- Report post
Hi Char42,
thanks for the article on Prolia. I'm looking for any studies about prolia taken after Forteo. I finish my last pen in November. I hoped to take denomusab, but my endo just told me that there were no studies about Deno (Prolia) after Forteo. Anyone hear anything?
- By Char42
- Posted October 21, 2009 at 3:56 am
- Report post
Hey Raven1, I have not read any data about Prolia after Forteo, guess we will have to wait until it is approved and read the small print. Not sure why this would be a concern after Forteo is finished. I think in clinicals Prolia was used after Bisphosphonates.
I will read on when I see more Prolia articles.
- By Raven1
- Posted October 23, 2009 at 3:51 pm
- Report post
I have to take something to maintain my bone buildup or i'll lose it. My endo told me that one of her patients took Actonel after taking Forteo and lost everything she gained on Forteo, so, studies are needed to see if Prolia works after Forteo. I'm glad to hear that it works after bisphosphonates. Also, what about the cost of Prolio, and will Insurance cover it?
- By Char42
- Posted October 24, 2009 at 6:36 am
- Report post
Hey Raven,
Prolia is given an in Doctors office; I do not know how this will play out with my Medicare/Supplement. Probably permission is needed from the Supplement. As for cost I am hearing $800 per injection could more or less.
I am more concerned about my bones than the cost of Prolia. Esorb cost me about $400 to $500 per year. Add to that the cost of Vit D, all out of pocket. Has that stuff made a big difference, not really, hopefully Esorb/D is maintaining my bones.
- By OWIE
- Posted October 24, 2009 at 10:58 am
- Report post
Any news on side effects from Prolia? or Denosumab?
- By BoneLady
- Posted October 26, 2009 at 12:00 pm
- Report post
One clinical trial followed 314 patients on denosumab, 46 on placebo, and 46 on alendronate. These were the adverse events for the denosumab group:
Any adverse event: 274 (87.3%)
Serious adverse event: 18 (5.7%)
The serious adverse events break down as follows: Neoplasm 6 (1.9%), Infection 3 (1.0%), Cardiac disorder 2 (0.6%), General disorder 2 (0.6%), Musculoskeletal or connective-tissue disorder 2 (0.6%), Injury, poisoning, or procedural complication 1 (0.3%), Abnormal clinical laboratory investigation 1 (0.3%), Nervous system disorder 1 (0.3%), Vascular disorder 1 (0.3%), Metabolic and nutritional disorders 0.
There were no deaths. Seven people (2.2%) on denosumab withdrew from the study due to adverse events. Twelve subjects (3.8%) on denosumab had a clinical fracture. One subject had both a lumbar vertebral fracture and a fracture of the radius and ulna.
To see results for the placebo group and the alendronate group, see Table 2. Adverse Events in the original article at
http://content.nejm.org/cgi/content/full/354/8/821#T3
Add to the discussion