Hungtington’s Orphan Drug Xenazine Clears FDA With REMS
This article was originally published in The Pink Sheet Daily
The first drug approved in the U.S. for any symptom of Huntington’s, Prestwick’s tetrabenazine will launch by year end.
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The PBT2 compound boosts executive function in first Phase II trial, but fails all other efficacy endpoints; however, past regulatory experience suggests that with few treatment options, one endpoint can do the trick in hard-to-treat Huntington’s disease.
Unmet need is high in Huntington’s disease and the protracted review of Xenazine – the only drug cleared for the disease by FDA – suggests regulatory precedent for approval based on just one efficacy endpoint and with lots of development and safety baggage.
Canadian drug maker is planning to launch Staccato loxapine and embark on an ambitious clinical program for pimavanserin in 2011.