Catalyst Pharmaceuticals on Wednesday announced that it filed a lawsuit against the FDA following its recent clearance of Jacobus Pharmaceutical's Ruzurgi (amifampridine) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in paediatric patients. The litigation claims that the approval violates multiple provisions of agency regulations regarding labelling, as well as Catalyst's statutory rights to orphan drug and new chemical entity exclusivity for Firdapse (amifampridine), which is authorised for the treatment of LEMS in adults. Catalyst CEO Patrick McEnany said "we believe the FDA has misapplied its regulations, contradicting decades of precedent and has undercut Catalyst's orphan drug exclusivity."
Specifically, Catalyst's concern is that although Ruzurgi was approved by the FDA for use in children, the treatment could also be potentially prescribed to adults on an off-label basis. Firdapse was authorised by the FDA last year for the treatment of LEMS in adults.
Catalyst launched Firdapse at an annual net price of more than $300 000 after US Senator Bernie Sanders questioned why the treatment, which had been available for free under a compassionate use programme, carried a list price of $375 000 per year. Meanwhile, Ruzurgi is comparatively priced at $175 200 per year.
"We think perhaps the FDA was improperly influenced by political pressure regarding high drug prices and we also feel that this is a horrible precedent for companies that are developing drugs to treat rare diseases," commented McEnany, continuing "if it is used according to label, which is for paediatric patients, it won't affect our market at all."
Catalyst licenced North American rights to Firdapse from BioMarin Pharmaceutical in 2012, while the companies' agreement was expanded to include Japan last month. Firdapse amassed $12.4 million in revenue in the first quarter.
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