FDA Shouldn’t Have Approved Drug from Jacobus, Says Appeals Court

October 5, 2021

A federal appeals court has ruled that the FDA incorrectly approved a rare disease drug from Jacobus Pharmaceuticals because Catalyst Pharmaceuticals already owned the rights to the drug.

Catalyst filed suit in the U.S. District Court for the District of Southern Florida in 2019, alleging that the FDA violated the company’s Orphan Drug seven-year exclusivity protections for Firdapse by approving Jacobus’ Ruzurgi, which contains the same active ingredient, amifampridine.

Firdapse was approved in 2018 for treating the autoimmune disease Lambert-Eaton myasthenic syndrome (LEMS) in adults. And Jacobus won FDA approval a year later for Ruzurgi as an LEMS treatment in children. But Catalyst maintained that Ruzurgi still ran afoul of its patent rights because physicians were prescribing the drug “off-label” for adults.

“Because it is undisputed that Catalyst held the exclusive right to market Firdapse,” and none of the statutory exceptions to market exclusivity apply, “Catalyst is entitled to summary judgment in its favor,” wrote the three judges from the U.S. Court of Appeals for the Eleventh Circuit.

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