Catalyst sues FDA to block treatment for children with rare disease

13 June 2019

New legal action from Catalyst Pharmaceuticals (Nasdaq: CPRX) signals the Florida, USA-based firm’s intention to strongly defend its market share in the rare disease Lambert-Eaton myasthenic syndrome (LEMS).

Catalyst won US Food and Drug Administration approval for its option, Firdapse (amifampridine), towards the end of 2018. The firm’s suit relates to the FDA’s recent approval of a rival therapy based on the same active ingredient.

Ruzurgi (amifampridine), from Jacobus Pharmaceutical, was approved for the treatment of children with LEMS in May 2019, sending shares in Catalyst down 40%.

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