January 10, 2022 — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported that the 11th Circuit Court of Appeals has denied Jacobus Pharmaceutical Company Inc.’s petition for rehearing of the 11th Circuit’s prior ruling to overturn the U.S. Food and Drug Administration (FDA) approval of Ruzurgi® for pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) based on the orphan drug exclusivity of FIRDAPSE®. Catalyst expects that the mandate to the District Court with instructions to enter summary judgment for Catalyst will be issued in the near future.
Patrick J. McEnany, Catalyst’s Chairman and CEO stated: “Catalyst’s priority has always been, and will continue to be, to put patients’ needs first, and we are well prepared to address their questions and do everything we can to ensure that ALL LEMS patients continue with uninterrupted access to amifampridine for treating their LEMS condition, whether through commercial access or compassionate use access for those who qualify. Our patient-focused Catalyst Pathways® team stands ready to provide information to patients currently being treated with Ruzurgi on how best to transition to FIRDAPSE.”
Information for Prescribers and Patients is available at 1-833-422-8259 and www.yourcatalystpathways.com.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases. Catalyst’s New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome (“LEMS”) was approved in 2018 by the U.S. Food & Drug Administration (“FDA”), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. Further, Canada’s national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.
