FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims

Catalyst Pharmaceuticals Inc.'s suit against the US Food and Drug Administration over its approval of a competitor's product has disclosed emails between agency staff that suggest they responded to pressure to address the price of Catalyst's drug.

Catalyst filed suit against the FDA in June 2019 challenging its approval of Jacobus Pharmaceutical Company Inc.'s drug Ruzurgi (amifampridine) despite the fact Catalyst had orphan exclusivity for Firdapse (amifampridine). Firdapse was approved in 2018 as a treatment for adults with Lambert-Eaton myasthenic syndrome (LEMS), while Ruzurgi was approved for pediatric use in LEMS in May 2019