Catalyst Pharma sues FDA after agency approves Jacobus’ LEMS drug

pharmafile | June 13, 2019 | News story | Business Services, Manufacturing and Production FDA, Jacobus, catalyst, firdapse, pharma, ruzurgi 

Florida firm Catalyst Pharmaceuticals is suing the FDA after the agency approved a rival’s drug.

The lawsuit alleges the approval of Jacobus Pharmaceutical’s Lambert-Eaton Myasthenic Syndrome (LEMS) drug Ruzurgi (amifampridine) infringes on Catalyst’s drug Firdapse’s right to market exclusivity.

Jacobus claim that Ruzurgi will compete with Firdapse through being prescribed off-label. Firdapse costs twice as much as Ruzurgi.

The case comes after Jacobus had since the 1990s been giving patients their own version of Firdapse for free through an FDA programme called compassionate use.

The programme came to an end last year after Catalyst gained FDA approval for Firdapse in 2018. Catalyst charge patients using Firdapse $375,000 a year.

The high price drag was immediately controversial attracting widespread criticism from politicians including senator Bernie Sanders who asked Catalyst to justify the price tag of $375,000 a year.

While both Catalyst’s and Jacobus’ drugs are approved for LEMS, Catalyst’s Firlapse is approved for adults while Jacobus’ Ruzurgi is approved for children. Jacobus’ treatment costs $175,000 a year. The approval of Ruzurgi for children may see it prescribed for adults off-label.

“If it is used according to label, which is for pediatric patients, it won’t affect our market at all,” Catalyst Chief Executive Officer Patrick McEnany said to Reuters.

“FDA has never approved orphan drug exclusivity (ODE) for a pediatric orphan drug subpopulation when the same applicant was barred by ODE from marketing to adult patients,” the complaint says.

“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,” he added.

Louis Goss

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