ViiV/GSK NNRTI "761" Development Placed on Hold by FDA
February 16, 2011
A promising non-nuke (NNRTI) in development by ViiV, GSK761 (formerly IDX899) was placed on clinical hold by the FDA due to four reports of seizure as part of the Phase 2b trial in treatment experienced patients. Two letters have been sent to study investigators informing them of the events, and including guidance on how to contact patients in order to change their medication from 761 to another suitable alternative and for follow up care.
While this does not mean that development of the drug has been permanently halted, it remains to be seen what the future holds for this drug which, in earlier studies, had shown an improved resistance profile compared to some of the current NNRTIs.
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