Federal Judge Rules in FDA’s Favor in Catalyst Suit over LEMS Drug

Rare Daily Staff

A federal judge granted summary judgement in favor of the U.S. Food in Drug Administration over its approval of Jacobus Pharmaceutical’s LEMS drug Rusurgi and dismissed a suit brought by Catalyst Pharmaceuticals.

The ruling adhered to recommendations at the end of July in a report and recommendations from a magistrate judge filed to the district judge handling the case saying the FDA’s and Jacobus’ motions for summary judgement should be granted and Catalyst’s motion for summary judgement denied.

In June 2019, Catalyst filed a lawsuit against the FDA demanding it vacate its approval of Jacobus’ 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. LEMS is a rare autoimmune condition in which the body attacks the junction between nerves and muscles.

The lawsuit was part of an ongoing controversy over the price of a drug (amifampridine) that had been 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 its drug at an annual list price of $375,000 along with a patient assistance program. The price sparked public outrage.

Only a few months after the Catalyst approval, the FDA approved Jacobus’ LEMS drug for use in pediatric patients based on data from studies of adult LEMS patients. Jacobus announced that it was pricing its LEMS pill at just under half the cost of a similar dosage of Catalyst’s pill.

Catalyst argued 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 under the Orphan Drug Act as well as other provisions.

But the district judge found that Catalyst’s interpretation of the Orphan Drug Act that the relevant statutory language in the Orphan Drug Act was ambiguous, and adopted FDA’s interpretation rather than Catalyst’s.  The District Judge also rejected Catalyst’s argument that the approved labeling for Ruzurgi is false and misleading.

As a result of the judge’s decision, Ruzurgi remains approved for the treatment of pediatric LEMS patients in the United States.

Patrick J. McEnany, CEO of Catalyst, expressed disappointment in the ruling and said it would not affect its ongoing efforts to market Firdapse. The company intends to appeal the ruling.

Photo: Patrick McEnany, chairman and CEO of Catalyst Pharmaceuticals