GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: Orphan designation

Unlike a Fast Track designation, which is all but meaningless, an Orphan Drug designation is consequential.

By granting ATryn an orphan designation even though a plasma-derived antithrombin (Talecris’ Thrombate) is already approved in the US for the HD indication, the FDA is implicitly stating that the benefits of a recombinant drug vs a corresponding plasma-derived drug are substantial.

We already knew this (#msg-23864419), but today’s news is a clear indication that the FDA knows it too.