Biotech Values

[DewDiligence]

Notes on the ATryn label:
(from the GTCB ymb):

>>
Re: Surgery not pregnancy
by: DewDiligence
06/04/06 08:28 pm
Msg: 32551 of 32551

>It seems that ATryn was recommended to be approved for surgery and not pregnancy. Is this correct and can someone explain why? Is this correct and can someone explain why?<

GTC needs to refine the dosing regimen for the childbirth setting. (If you recall, this was the reason the EMEA discarded the pregnant patients in the original review.)

GTC will collect more data on the childbirth setting in the U.S. phase-3 trial and submit these data to the EMEA for a label expansion in 2007 or 2008.

From an economic standpoint, the lack of a childbirth indication in the initial HD label has a negligible consequence. Regards, Dew

[Posted as a reply to: Msg 32549 by black_knight_765]
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