Catalyst Sues FDA Over Approval of Rival Drug

Regulatory NewsRegulatory News | 12 June 2019 |  By 

Catalyst Pharmaceuticals on Wednesday sued the US Food and Drug Administration (FDA) because of the agency’s recent approval of rival Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS).

Ruzurgi, which was approved by FDA in May for children with LEMS, will likely compete off-label with Catalyst’s Firdapse (amifampridine), which first won approval in November 2018 but has a list price about twice as high as Ruzurgi. Soon after Jacobus’s approval for Ruzurgi, Catalyst’s stock price fell by about 40%.

In its complaint, Catalyst contends that FDA’s approval of Ruzurgi should have “been barred by multiple provisions of law” and that FDA is facilitating Jacobus’s off-label marketing of Ruzurgi. Catalyst noted that FDA issued “at least one official letter communicating to adult LEMS patients that they should consult their physicians regarding the potential use of Jacobus’s product for LEMS—even though that drug was only approved for pediatric patients—rather than Catalyst’s product.”

Last month, Sen. Bernie Sanders (D-VT) called the Ruzurgi approval “a victory for patients with LEMS.”
But Catalyst maintains that orphan drug exclusivity (ODE) should have barred Jacobus from winning approval for Ruzurgi.

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

Catalyst further explains how Jacobus’s drug labeling “unambiguously violates FDA’s regulations” by communicating in multiple separate provisions that the drug can be safely and effectively used for adult patients, even though it has only been approved for use in children.

Catalyst also explains how FDA applied a different approval standard for Ruzurgi when compared to Firdapse.

“FDA arbitrarily treated Catalyst differently than Jacobus. For example, FDA allowed Jacobus to submit studies and clinical trials post approval that it required Catalyst to submit before FDA would even consider an NDA submitted by Catalyst for Firdapse.  Specifically, Catalyst was required to submit the results of an animal toxicology study and a clinical trial to evaluate the effect of Firdapse on kidneys before Firdapse was reviewed, while FDA permitted Jacobus to conduct a juvenile animal toxicology study and a clinical trial to evaluate the effect of Ruzurgi on kidneys after the Agency approved Ruzurgi,” the complaint says.


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