A pharmaceutical company announced Tuesday it will move forward with standard federal approval procedures for its rare disease medication after the Food and Drug Administration turned down its application for expedited review.
Disc Medicine revealed that federal regulators declined to approve bitopertin through the agency’s accelerated review system. Last month, Reuters reported exclusively that FDA officials had delayed the drug’s evaluation by two weeks due to questions about clinical trial information and concerns regarding potential misuse.
The medication had been under consideration through the FDA’s national priority voucher system, which reduces review time to one or two months compared to the standard 10-12 month timeline.
Company CEO John Quisel noted that policy discussions surrounding accelerated drug approvals have continued through several presidential administrations, with recent regulatory actions indicating federal officials are taking a more cautious approach to such expedited approvals.
The pharmaceutical firm indicated it anticipates receiving final-stage trial results during the fourth quarter of this year.
