FDA accepts application for Ryplazim (plasminogen replacement therapy) in plasminogen deficiency.- Prometic Life Sciences.
Prometic Life Sciences announced that the FDA has accepted its Biologics License Application (BLA) for Ryplazim (plasminogen replacement therapy) having granted a priority review status and set a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018. Prometic has previously reported data from this pivotal Phase II/III trial, which showed that Ryplazim treatment consistently replaced and maintained the plasminogen concentration at an appropriate level and that it resolved all lesions in all patients treated.
Comment: The FDA has demonstrated the urgency of tackling plasminogen deficiency, granting orphan, fast-track and rare pediatric disease designations to the drug. If approved, Prometic's plasminogen replacement therapy will be eligible for a rare pediatric disease priority review voucher.
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