Unmet Need Helped Boehringer's Ofev Win Favorable Advisory Cmte. Vote For New Indication – Or Did It?
US FDA's Arthritis Advisory Committee members who qualified their votes in recommending approval for Ofev to treat SSc-ILD could complicate the agency’s decision.
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Boehringer Avoids Further Efficacy Study Of Ofev In SSc-ILD With Full Approval, No Post-Marketing Commitments
Despite concerns from members of US FDA's Arthritis Advisory Committee that the efficacy profile of Boehringer Ingelheim's Ofev needs more study in the SSc-ILD indication, the company does not have any such postmarketing requirements or commitments.
Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA's Arthritis Advisory Committee narrowly votes to expand label for BI's nintedanib for treatment of systemic sclerosis associated interstitial lung disease, with panelists split on whether further data on its risk/benefit profile can be gathered post-approval.