MCatalyst Pharmaceuticals has filed a lawsuit against the U.S. Food and Drug Administration demanding that it vacate its recent approval of Jacobus Pharmaceutical’s drug Ruzurgi for the treatment of Lambert-Eaton Myasthenic Syndrome, or LEMS, in pediatric patients. Catalyst’s drug Firdapse was approved in late 2018 to treat adults with LEMS.

The lawsuit is the latest chapter in an ongoing controversy over the price of a drug (amifampridine) that was available for free from Jacobus under an FDA compassionate use program. That ended when the FDA approved Catalyst’s Firdapse in late November 2018. Catalyst then proceeded to price the drug at an annual list price of $375,000 along with a patient assistance program. The price sparked a public outrage with Vermont Senator Bernie Sanders sending a letter to Catalyst demanding it to justify the price and citing the company for an “immoral exploitation of patients who need this medication.”

Only a few months after the Catalyst approval the FDA approved Jacobus’ LEMS drug for use in pediatric patients that was based on data from studies of adult LEMS patients. Jacobus did not immediately reveal what it would charge for Ruzurgi but the idea was that there would now be two available treatments for LEMS and doctors would be free to prescribe the Jacobus drug to adults with LEMS.

On June 11, Jacobus revealed that it was pricing its LEMS pill at just under half the cost of a similar dosage of Catalyst’s pill. The next day, Catalyst filed suit. Catalyst thinks the approval of Jacobus’ Ruzurgi was an illegal regulatory workaround of its seven years of exclusivity for Firdapse. While a drug approved for pediatric use can be prescribed off-label for adults, a drug approved for adult use cannot be prescribed for pediatric patients.

Its complaint alleges that the FDA’s approval of Ruzurgi violates multiple provisions of FDA regulations regarding labeling, resulting in misbranding in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), and violates Catalyst’s statutory rights to Orphan Drug Exclusivity and to New Chemical Entity Exclusivity under the FDCA. Catalyst claims the approval of Ruzurgi was arbitrary, capricious, contrary to law, and in violation of the Administrative Procedure Act.

“We believe the FDA has misapplied its regulations, contradicting decades of precedent and has undercut Catalyst’s orphan drug exclusivity,” said Patrick McEnany, chairman and CEO of Catalyst Pharmaceuticals.

Photo: Patrick McEnany, chairman and CEO of Catalyst Pharmaceuticals

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