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Catalyst Pharmaceuticals Receives Positive Decision from Appeals Court That Supports Orphan Drug Exclusivity for Firdapse® for LEMS
CORAL GABLES, Fla., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage, patient-centric
About this update from Catalyst Pharmaceuticals, Inc.
[{"type":"text","content":"CORAL GABLES, Fla., Sept. 30, 2021 (GLOBE NEWSWIRE) -- 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 it has received a positive decision from the 11th Circuit Court of Appeals in its appeal to overturn a District Court decision upholding the U.S. Food and Drug Administration’s (FDA) approval of another amifampridine product, Ruzurgi®, for pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) despite existing Orphan Drug exclusivity for Catalyst’s Firdapse® (amifampridine) Tablets 10 mg. With this ruling, the 11th Circuit Court panel has reversed the District Court’s decision and remanded the matter to the District Court with instructions to enter summary judgment for Catalyst. The Court's decision adopted Catalyst’s core argument that the FDA’s approval of Ruzurgi® violated Catalyst's rights to Orphan Drug Exclusivity. “We are extremely pleased with the 11th Circuit Court’s decision and are hopeful that it brings to a close this case that is not just important for Catalyst, but for all patients living with rare diseases who depend on medicines that would not be available if not for the efforts and investment of pharmaceutical companies willing to pursue these indications,” said Patrick J. McEnany, Catalyst’s Chairman and CEO. \"The purpose of the Orphan Drug Act is to encourage pharmaceutical companies to make the R&D investments necessary to bring FDA-approved therapies to patient populations living with very rare diseases, and the biggest incentive the Orphan Drug Act provides is the ability to have an exclusive market within that rare disease for their drug for seven years once they obtain approval. The Orphan Drug Act has proven successful for the more than 350 rare diseases that now have an FDA-approved treatment, but there still remains about 6,500 rare diseases that do not have an approved therapy – and the incentives to develop drugs to treat these rare diseases need to remain intact. This decision increases the hope for the patients living with these diseases that one day soon an approved drug for their rare disease might be a reality. This is a goal that we feel we share with the FDA despite ...