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Originally Posted by Sassiesmom
I just read in our local newspaper last night about the once a year infusion called Reclast by Novartis that is about to be approved. Does anyone have any information about this drug?  |
Hi Sassiesmom: I just read about this drug, and Novartis has applied for an NDA (new drug application) with the FDA on 9-16-06. It's also known as zoledronic acid, which has been around for awhile. Unfortunately, I don't know how long it takes the FDA to approve these drugs, but from everything I read, Forbes, Novarits, other osteo web sites etc, they say it seems "promising". I'm not sure how they come to that conclusion, since the final stage is up to the FDA, but since it's a *once* a year *15 mins* infusion, they feel it will help a lot with patient compliance, and also for the patients that can't tolerate oral bisphosphonates, due to the intestinal, and esophageal probs. In the clinical trials, the most common side effect after 3 days was: headache, fatigue, and bone pain. After that amount of time the effects seem similar to oral bisphos... w/o the instestinal probs. I couldn't find anything on the half life of the drug, but am sure anyone interested could find that info out thru various sources.
The company claims that it decreases spinal fractures by 70% and 40% in hip fractures and helps fracture prevention in other areas of the body (paraphrased). Make sure you verify this, to make sure my figures are correct. One thing that wasn't mentioned was how long it takes to get these percentage increases, but these figures are quite high, so I hope it is accurate, over a period of time. I have found that when you read these precentage claims, they tend to leave out the amount of treatment that is necessary to reach such a high % rate success.
Good Luck, if you're considering this... And I hope it doesn't take long to get the FDA to put it on the market.
Pam
Reclast????
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