Potential first-in-class treatment for SCD awarded FDA priority review

The U.S. Food and Drug Administration (FDA) has granted priority review — a decision that could speed a drug’s approval — to an application for the oral therapy mitapivat for sickle cell disease (SCD).

According to developer Agios Pharmaceuticals, mitapivat, if approved, will be the first therapy of its class for people with SCD in the U.S.

Priority review means the FDA will expedite its regulatory evaluation, completing it in six months instead of the usual 10. A final decision on whether or not to clear mitapivat for use in SCD is now expected by Nov. 1, the developer noted in a company press release.