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Human Growth Hormone and Lipodystrophy
Jun 2, 2006

I recently read that Serono has completed Phase 3 trials of HGH for lipodystrophy. The results seem promising. I have 2 questions: Do you expect the FDA to approve HGH for lipodystrophy, and if so...when? Do you think most insurance companies will cover HGH for the treatment of lipodystrophy? Currently I am insured under Humana and they only cover HGH for the treatment of AIDS wasting. Thank you very much

Response from Dr. Pierone

Based on the results that I have seen presented at meetings it looks like hGH does help reduce intra-abdominal fat deposition and cervico-dorsal fat pad (buffalo hump) size. Unless any major safety concerns come up in the phase 3 trials it seems reasonable that this agent may get FDA approval for a lipodystrophy indication. I don't know where the company is in the regulatory process so can't comment on the time-line.

If it does get approval it will then be up to the insurance companies to decide whether to pay for it for their insured members. This decision depends on many factors and is hard to predict. One of the challenges is that hGH (Serostim) is quite expensive (would you like a new automobile or 3 months of Serostim?) and lipodystrophy benefits would likely recede after it is stopped.

Thanks for posting and stay tuned.



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