Further Analyses To Delay Ipsen’s Palovarotene Progress In Ultra-Rare Disease
Withdraws US Marketing Submission
Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.
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Despite concerns over toxicity due to early growth plate closure in skeletally immature patients, Ipsen's CEO David Loew is confident that palovarotene will get through regulatory review for fibrodysplasia ossificans progressive.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.