Savient Suggests More Restrictive REMS Plan For Pegloticase In BLA Amendment
This article was originally published in The Pink Sheet Daily
Executive Summary
PDUFA date shifts to July 30; FDA to reschedule advisory committee.
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Savient's Gout Therapy Krystexxa Delayed At FDA.
Manufacturing fixes should be straightforward - but the REMS submission could be tricky.
Savient's Gout Therapy Krystexxa Delayed At FDA.
Manufacturing fixes should be straightforward - but the REMS submission could be tricky.
Savient's Gout Therapy Krystexxa Delayed At FDA
The biggest delay in Savient's resubmission of its gout therapy Krystexxa (pegloticase) could come from FDA's request that the sponsor include detailed materials for its Risk Evaluation and Mitigation Strategy as part of the resubmission