FDA to continue to grant orphan exclusivity for sub-populations

FDA announced Monday that it will continue to tie orphan-drug exclusivity to uses or indications, despite a federal court’s decision that the law requires it to grant exclusivity to an entire disease or condition.

The agency stated that it was “clarifying” its policy “in light of the recent decision by the U.S. Court of Appeals for the Eleventh Circuit in Catalyst Pharms., Inc. v. Becerra.” The court ruled in September 2021 that FDA violated the Orphan Drug Act when it granted Jacobus Pharmaceutical Co. Inc. orphan exclusivity for use of Ruzurgi amifampridine to treat children with Lambert-Eaton myasthenic syndrome (LEMS). ...