Federal Judge Backs Neurelis, Rules FDA Violated Orphan Drug Act

A federal judge ruled in favor Friday of drugmaker Neurelis and canceled the FDA’s approval of a rival manufacturer’s similar medication to treat acute repetitive seizures.

US District Judge Amit P. Mehta’s memorandum opinion ruled the Food and Drug Administration violated the Orphan Drug Act in 2024 when it approved Aquestive Therapeutics Inc.’s drug, Libervant, to treat acute repetitive seizures during a period of exclusivity for Neurelis Inc.'s drug, Valtoco.

The Orphan Drug Act is designed to encourage the creation of medications to treat rare conditions. It provides a seven-year period of marketing exclusivity for a first-to-market “orphan drug” that ...