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Unmet Need Helped Boehringer's Ofev Win Favorable Advisory Cmte. Vote For New Indication – Or Did It?

Executive Summary

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.

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