As the FDA has in the past when a court issued an opinion it didn’t agree with, the U.S. agency is trying to limit the fallout from an appellate court ruling in Catalyst Pharmaceuticals Inc. vs. Becerra, which involved the breadth of orphan drug exclusivity, to that case alone.
The FDA’s 2019 approval of Jacobus Pharmaceutical Co. Inc.’s Ruzurgi to treat children ages 6 to 17 with Lambert-Eaton myasthenic syndrome must be set aside because it violated the Orphan Drug Act in light of Catalyst Pharmaceuticals Inc.’s seven-year orphan exclusivity for its LEMS drug, Firdapse, the U.S. Court of Appeals for the 11th Circuit ruled Sept. 30.
