Ipsen Positive On Palovarotene Despite Troubled Past
Filings For FOP In Early 2021
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.
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Panel to review overall survival data on GSK’s Zejula for ovarian cancer ‘is no longer needed,’ US FDA says. Meeting to consider pediatric indication for Viatris’ Revatio was also cancelled though sNDA remains active. FDA to review new information on Ipsen’s palovarotene clinical trial data.
David Loew has assembled a strong business development team which secured seven licensing pacts in 2021 and the Ipsen CEO tells Scrip that this year should see more of the same.
Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.