Savient's Gout Therapy Krystexxa Delayed At FDA
This article was originally published in Pharmaceutical Approvals Monthly
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
You may also be interested in...
SAN DIEGO - Industry is hoping an upcoming Risk Evaluation and Mitigation Strategy guidance document will outline a more transparent process regarding the FDA's REMS decisions
Savient's Krystexxa, an orphan drug candidate for treatment-failure gout, could bring in $600 million or more in worldwide sales by 2015, considerably bumping up the firm's potential value and making it pretty enough for picking as a potential acquisition candidate - or at the very least a collaboration partner
Now that gout drug candidate Krystexxa has passed muster with FDA's Arthritis Drugs Advisory Committee, its next major hurdle is agency approval. But with only six weeks to go until its Aug. 1 user fee date and what's expected to be a fairly complex Risk Evaluation and Mitigation Strategy, odds are FDA will be unable to meet that timeline