Feb 17 (Reuters) - Disc Medicine ( IRON ) 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.