Feb 17 (Reuters) – Disc Medicine said on Tuesday it will pursue a traditional U.S. approval pathway for its rare disease drug after the Food and Drug Administration declined to approve the treatment under a new fast-track review program. Reuters had exclusively reported last month that FDA reviewers pushed back bitopertin’s review by two weeks on concerns about trial data and its risk for abuse.
The drug, bitopertin, was previously reviewed under the FDA’s national priority voucher program, which fast-tracks the process to one to two months from the typical 10-12 months.
Disc CEO John Quisel said the policy debate over accelerated approval has stretched across multiple U.S. administrations, and recent regulatory decisions suggest an increasingly stringent view on when such approvals are appropriate.
The company said it expects late-stage data in fourth-quarter this year.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)
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