Exhibit 99.1
Catalyst Pharmaceuticals Receives U.S. FDA Approval For Increased Maximum
Daily Dose For FIRDAPSE®
CORAL GABLES, Fla., May 30, 2024 — Catalyst Pharmaceuticals, Inc. (“Catalyst” or
“Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its supplemental New Drug Application (“sNDA”)
increasing the indicated maximum daily dose of FIRDAPSE® (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for the treatment of Lambert-Eaton
myasthenic syndrome (“LEMS”). The increased maximum daily dose offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS.
LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. FIRDAPSE is a potassium channel blocker indicated for the
treatment of LEMS in adults and pediatric patients six years of age and older and works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, which helps improve muscle function in people with LEMS. FIRDAPSE
is currently the only U.S. approved treatment for LEMS and this approval broadens the approved dosing options for prescribers treating LEMS.
“We are pleased to receive the approval for the increased maximum daily dose of FIRDAPSE,” said Richard J. Daly, President and CEO
of Catalyst. “This pivotal achievement further underscores our dedication to meeting the evolving needs of LEMS patients and their healthcare providers. We believe that this milestone will have a meaningful impact on the lives of LEMS patients,
offering a new level of flexibility in treatment while aligning with our overarching mission to optimize LEMS patient outcomes.”
Patients in the U.S. can access FIRDAPSE by prescription through their healthcare providers. For those seeking more information, the
Catalyst Pathways® Patient Assistance Program for FIRDAPSE® offers comprehensive support, including a dedicated team to assist
families throughout the treatment journey for eligible patients. Caregivers and healthcare professionals may call 1-833-422-8259
or visit www.yourcatalystpathways.com for further details.
For additional information, please visit the company website at
Catalyst Pharmaceuticals.
About Catalyst Pharmaceuticals, Inc.
With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare and difficult-to-treat diseases. Catalyst’s flagship U.S. commercial
product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”) for adults and for children ages six to
seventeen. In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and
older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.
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. On July 18, 2023, Catalyst acquired an exclusive
license for North America for AGAMREE® (vamorolone) oral suspension 40 mg/mL, a novel corticosteroid treatment for Duchenne Muscular Dystrophy. AGAMREE previously received FDA Orphan
Drug and Fast Track designations and was approved by the FDA for commercialization in the U.S. on October 26, 2023. AGAMREE became commercially available by prescription in the U.S. on March 13, 2024.