Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) Receives Favorable Judgment From Appellate Court in Suit Against FDA concerning Ruzurgi Approval 

Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) has announced that the US Court of Appeals of the 11th Circuit has given a mandate requiring the District Court that presided over the company’s claim against the FDA to enter summary judgment in favor of the biopharmaceutical company in the suit against the agency, thus vacating the FDA’s clearance of Jacobus Pharmaceutical Compay’s Ruzurgi. 

Catalyst to guide patients on Ruzurgi to change to Firdapse

The company’s CEO and Chairman Patrick McEnany said, “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.”

Most importantly, the company’s patient-focused Catalyst Pathways crew is ready to offer information to patients currently receiving Ruzurgi to change to FIRDAPSE.

Catalyst is dedicated to building a comprehensive pipeline of best- or first-in-class treatments for various rare diseases, with a strong patient emphasis. The FDA approved its New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for Lambert-Eaton myasthenic syndrome (“LEMS”) treatment in 2018, and FIRDAPSE is now commercially accessible in the US as a treatment for people with LEMS. Furthermore, Health Canada, Canada’s national healthcare regulatory agency, has cleared the use of FIRDAPSE® for treating adult patients with LEMS in the country.

Catalyst granted RPDD for CB 4332

Recently the company announced that the US FDA had granted its Complement Factor I Deficiency treatment, CB 4332, a Rare Paediatric Disease Designation. The designation of CB 4332 as an RPDD highlights the huge unmet medical need in the pediatric population with CFID.

CEO Nassim Usman said, “We are focused on efficiently advancing the development of CB 4332 and our complement medicines portfolio in a number of complement-driven diseases in hematology, nephrology and ophthalmology. We are pleased with the FDA’s assessment of CB 4332 as a potential therapy for underserved pediatric patients with CFID and the granting of the RPDD.”