Jacobus Pharm's New Drug, Ruzurgi (Amifampridine) Receives approval in the U.S.
CORAL GABLES, Fla., Jan. 28, 2022 (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 the U.S. Court of Appeals for the 11th Circuit has issued a mandate directing the District Court that heard Catalyst's claim against the FDA to enter summary judgment in favor of Catalyst in its lawsuit against the FDA, thereby vacating the FDA's approval of Ruzurgi® (Jacobus Pharmaceutical Company's amifampridine product).
Enforcement Report - Week of October 6, 2021
Since it came online with a breakthrough drug for a rare autoimmune disorder, Lambert-Eaton myasthenic syndrome (LEMS), Catalyst Pharmaceuticals has had a running feud with another company that later won approval for the same condition.
Jacobus Pharmaceuticals Issues Voluntary Worldwide Recall of Ruzurgi 10 mg
After hinting it was exploring the legality of the FDA’s approval of a rival drug from family-run company Jacobus Pharmaceuticals, Catalyst Pharmaceuticals on Wednesday filed a lawsuit against the health regulator — effectively accusing the agency of bowing to political pressure surrounding skyrocketing drug prices.
After weeks of anticipation, Jacobus Pharmaceutical, a small, family-run drug maker, has priced its rare disease drug at $80 a tablet, or less than half the price of a similar pill sold by its upstart rival, Catalyst Pharmaceuticals (CPRX). And the move is likely to set up a closely watched battle amid what is already one of the more unusual pharmaceutical tales of the year.
Weeks ago, the FDA endorsed a Lambert-Eaton myasthenic syndrome (LEMS) drug from family-run New Jersey-based company called Jacobus Pharmaceuticals in pediatric patients, on the basis of adult data, to the surprise of Catalyst Pharmaceuticals which only last year got its pricey — yet similar — treatment for the rare autoimmune disorder across the finish line in adults. It has now been revealed that Jacobus’ version carries a price that is less than half of Catalyst’s Firdapse — a move that could fuel off-label prescription in adults.