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News > New osteoporosis drug, denosumab, slated for FDA review
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New Bone Drug Set for Review

Denosumab slated for FDA review

By Brenda Goodman

8/13/09 A panel of advisors to the Food and Drug Administration (FDA) is slated to review a new kind of osteoporosis drug on August 13. The agency is not bound by the recommendations of its advisory panels, but typically follows them.

The drug, denosumab, which may be brand-named Prolia, is a monoclonal antibody given by injection every six months, and it works by inhibiting a protein necessary to cells called osteoclasts, which break down bone.

In a head-to-head comparison with alendronate (Fosamax) published in the February 23, 2006 issue of The New England Journal of Medicine, denosumab increased bone density at the hip and spine at least as well, and in some cases, better than alendronate.

Manuel Rodriguez M.D.
24 Aug 2009, 13:36
This new drug will be very useful in the future for the treatment of osteoporosis. More information will be necessary after the approval of the FDA, which is expected to make a decision in October 2009.
Brenda Goodman, medical editor
24 Aug 2009, 12:27
Hi Pat,

Sorry you had such a hard time on Reclast.

Denosumab, however, is not the same kind of drug.

If the FDA signs off in the next few weeks, Denosumab will be the first biologic drug approved to treat osteoporosis.

You can read a more in-depth report on it here:
http://www.arthritistoday.org/news/denosumab-review.php

Kind regards,

Brenda Goodman
Pat H.
18 Aug 2009, 16:57
THIS SOUNDS LIKE RECLAST,ONLY TAKEN 6MOS.INSTEAD OF ONE YR.I had a terrible reaction to Reclast.took it JUNE 22 AND AM JUST RECOVERING FROM PAIN, DEPRESSION, ARTHRITIS PAIN IN MY THUMB JOINTS,HIP JOINTS,HAVE OSTEOPOROSIS IN MY HIPS DIDN'T BOTHER ME UNTIL THE INJECTION,MY THUMBS NEED BRACES WHEN I WORK AROUND THE HOUSE,,IT'S LIKE IT SETTLES IN WHERE YOU HAVE A PROBLEM.LOTS OF OTHER PROBLEMS,I WOULD'T ADVISE ANYONE TO TAKE IT.
AUGUST 18,A LONG TIME TO FEEL BETTER .

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