Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for FIRDAPSE® Expanding Patient Population to Include Pediatric Patients
"We are very pleased to have received FDA approval for the expanded pediatric indication for FIRDAPSE. While the
As part of Catalyst's efforts to help ensure those patients who can benefit from FIRDAPSE are able to obtain access, Catalyst offers a comprehensive patient access support program and patient assistance for qualifying LEMS patients through its Catalyst Pathways® program. More information is available for prescribers and patients by visiting www.yourcatalystpathways.com or by calling 1-833-422-8259.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, best-in-class medicines for rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and FIRDAPSE is commercially available in the United States as a treatment for adults and children ages six to seventeen with LEMS. 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.
For additional information about the Company, please visit www.catalystpharma.com.
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2021 and its other filings with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Investor Relations Contact:
Mary Coleman Catalyst Pharmaceuticals(305) 420-3200 firstname.lastname@example.org Media Contact: David Schull Russo Partners(858) 717-2310 email@example.com
Source: Catalyst Pharmaceuticals, Inc.