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Catalyst Pharmaceuticals Announces Ruling on Lawsuit against the FDA and Intent to Appeal
CORAL GABLES, Fla., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), today reported that the federal judge
About this update from Catalyst Pharmaceuticals, Inc.
[{"type":"text","content":"CORAL GABLES, Fla., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), today reported that the federal judge handling Catalyst's case against the FDA has adopted the previously reported Report and Recommendation of the Magistrate Judge, granted summary judgment in favor of the FDA and Jacobus, and dismissed Catalyst's case. Catalyst is currently reviewing the District Judge's decision, which it believes to be erroneous, and intends to appeal the result to the Eleventh Circuit Court of Appeals.\n In the order, the District Judge found that Catalyst’s interpretation of the Orphan Drug Act “is not necessarily wrong, but it is not the only reasonable way to interpret the plain language of the statute.” The District Judge found that the relevant statutory language 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 District Judge's decision, Ruzurgi® remains approved for the treatment of pediatric LEMS patients in the United States. Patrick J. McEnany, the Company's Chairman and CEO, stated: \"We are of course disappointed with Judge Bloom’s decision to accept the Magistrate’s Report and Recommendation in our lawsuit challenging the FDA’s decision to approve Ruzurgi® for the treatment of pediatric patients with Lambert-Eaton Myasthenic Syndrome (LEMS). This decision in no way affects our Catalyst PathwaysTM patient services programs, market access for Firdapse® or our ongoing marketing efforts for Firdapse® to adult LEMS patients, which represent about 99% of the LEMS patient community.\" Mr. McEnany continued: \"Judge Bloom’s decision also does not alter the fact that Jacobus Pharmaceuticals is not permitted to market Ruzurgi® to adult LEMS patients in the United States, and Catalyst intends to continue to aggressively take all steps necessary to protect Firdapse®’s exclusivity under the Orphan Drug Act.\" About Catalyst Pharmaceuticals Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthe...