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Tuesday, November, 24, 2009
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Blockbuster Osteoporosis Drug Moves Towards FDA Approval

PJ Hamel
PJ Hamel
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PJ Hamel is an osteoporosis don't-wannabe!
Writer, author, baker, daughter, mom, wife, friend

I'm a nationally noted food writer and author, with three...

PJ Hamel

Sunday, August 09, 2009
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Denosumab, a ground-breaking osteoporosis drug that’s been moving through clinical trials for several years, is set to take the first step towards FDA approval this week.   An advisory panel will meet Thursday to make recommendations as to whether denosumab, which will be marketed unde...
  1. Great SharePost!!
    Pam Flores
    Sunday, August 09, 2009 at 05:37 PM

    Boy I'm keeping my fingers crossed on this one!!  I'm one of those, don't believe it until I see it, regarding FDA approval, but it does look really good.  I've been following this particular drug for about 4 years and never thought this day would arrive.  Sure wish I had bought stock when it was really cheap, because it just keeps going up.

     

    What do you think about it's use for those undergoing estrogen ablation tx?  Interesting-eh?  My docs first reaction, about a two years ago, was luke warm, but last summer she attended the ASBMR's symposium on it where they presented the head to head with Fosamax and came back all jazzed about it.  Quite a turn-around from our first conversation when she told me I was being pretty optimistic thinking it would be approved and I could even consider it!  Her only concern seem to be it's ability to cause anaphalaxis, and infections since it's a antibody.  She felt there will be a lot of people who wouldn't be able to take it if they had auto-immune or similar probs.  Well as far as I know I don't have any of those, and so if it's approved I'll just have to wait and see *if* my insurance will pay for it with all the cut backs we've been seeing.  If they hold to this qualification of a -2.5 or lower lumbar score I may not qualify, unless they've changed that, or leave it up to the treating physician.

     

    Thanks again--this is good news--if the FDA doesn't have a change of heart for some reason.  Oh one thing, for everyone, keep your eye on *any* FDA post-marketing surveilance on it once it's available just to be on the safe side.  I'm in the midst of trying to decide what to do about the Forteo registry Eli Lily wants us to join, to track possible osteosarcoma in Forteo users.

     

    Great Job and News...Wink

     

     

    Reply
    re: Great SharePost!!
    PJ Hamel
    Sunday, August 09, 2009 at 06:33 PM

    Luckily, it sounds like it wouldn't be any more expensive than the bisphosphonates. Amgen seems to think it's going to get FDA approval, as I've seen some press releases already talking about its release in January '10. And I know - their stock is going crazy! We should have looked into our crystal ball sooner, eh? PJ

    Reply
    re: re: Stock issue
    Pam Flores
    Sunday, August 09, 2009 at 08:35 PM

    I sure wished I'd done something about my daily tracking of the stock.  I have Amgen's info prominently placed on my desktop at all times so I can see the constant changes in share prices.  Oh well, my mistake, I find I wait to long to act on my instincts :(

     

    Take Care and hope the Actonel side effects are easing up!  I hope they aren't too bad also.  Have you tried any PPIs for the side effects if your's are gi related?

    Reply
    re: re: re: Stock issue
    PJ Hamel
    Monday, August 10, 2009 at 06:01 AM

    My main issue seems to be weight gain! I started dieting last week. Other than that, I seem to have random bouts of nausea, but meditation works well there. Hate to reveal my ignorance, but what's a PPI? - PJ

    Reply
    re: re: re: re: Stock issue
    Pam Flores
    Monday, August 10, 2009 at 09:14 AM

    Hi PJ, Sorry I should have said that PPI's (proton pump inhibitors) are meds for nausea, heartburn, or acid reflux.Smile

    Reply
  2. Untitled Comment
    W R
    Thursday, August 13, 2009 at 05:05 PM

    For a clear indication of what is wrong with the US health system compare the two articles and their projected annual costs for Prolia/denosumab--$850-$1200 for the US and 80-100 Pounds in the UK, the rough equivalent of $130-$180.  I could fly to England twice a year and stil come out ahead.

    Reply
    re: Untitled Comment
    W R
    Thursday, August 13, 2009 at 05:13 PM

    Sorry--I just reread the UK article.  The correct cost quote is even cheaper:50 to 80 Pounds, or $84-$135!

    Reply
    re: re: Untitled Comment
    PJ Hamel
    Thursday, August 13, 2009 at 05:15 PM

    I know - it's because the British government refuses to pay what the drug companies want, so they have to take what the government will pay. Backwards here... sigh. Thanks for chiming in - PJH

    Reply
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