News & Events
Your online link to LEMS-related developments
Find the latest information about Lambert-Eaton myasthenic syndrome (LEMS), FIRDAPSE, and other related topics and events.
Increased Maximum Daily Dose for Firdapse is FDA Approved
FIRDAPSE Gains Pediatric Approval
COVID-19 and LEMS Patients
INCREASED MAXIMUM DAILY DOSE FOR FIRDAPSE IS FDA APPROVED31
In June 2024, Catalyst Pharmaceuticals, Inc., received FDA approval to expand the maximum daily dose of FIRDAPSE® (amifampridine) 10 mg Tablets from 80 mg daily to 100 mg daily for adult patients living with Lambert-Eaton myasthenic syndrome (“LEMS”).
“We are very pleased to have received approval for the 100 mg daily dose,” stated Patrick J. McEnany, Chairman and CEO of Catalyst. “This increase of the FIRDAPSE dosing ceiling ensures that adult patients at the upper end of the FIRDAPSE dosing range may continue to benefit from physician-guided titration to help them maintain the optimal therapeutic benefit from their medication.
“This milestone is yet another demonstration of our long-standing and unwavering commitment to the LEMS patient community, and we are pleased that this expanded dosing schedule is now available for our patients. We look forward to building upon our recent achievements with a sustained focus on addressing the needs of LEMS patients. We thank the Agency for their collaboration during the review of this application and our Catalyst employees for their shared commitment to improving the lives of commitment to improving the lives of patients.”
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.
Learn more about firdapse dosing.
Discover key aspects of FIRDAPSE dosing for adult and pediatric patients, including the importance of titration, modifications for certain patients starting FIRDAPSE, and additional helpful information.
FIRDAPSE GAINS PEDIATRIC APPROVAL31
On September 29, 2022, Catalyst Pharmaceuticals, Inc., received FDA approval to expand the indicated age range for FIRDAPSE (amifampridine) Tablets 10 mg to include pediatric patients 6 years of age and older for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”). FIRDAPSE is currently approved in the US and Canada for the treatment of LEMS in adult patients.
“We are very pleased to have received FDA approval for the expanded pediatric indication for FIRDAPSE. While the US LEMS pediatric population is an exceptionally small number of patients, this positive outcome helps ensure that all eligible LEMS patients have access to FIRDAPSE for the treatment of this rare disease,” stated Patrick J. McEnany, Chairman and CEO of Catalyst.
“This milestone represents our long-standing and unwavering commitment to the LEMS patient community, and we are pleased that this medicine is now available for this important patient population. We look forward to building upon our recent achievements with a sustained focus on addressing the needs of LEMS patients. We thank the Agency for their collaboration during the review of this application and our Catalyst employees for their shared commitment to improving the lives of patients.”
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.
COVID-19 AND LEMS PATIENTS
In 2020, the COVID-19 Working Group—an international coalition of physicians and scientists—released treatment guidelines for patients with LEMS and related neuromuscular conditions during the coronavirus pandemic.37 Since that article was published, the situation has evolved significantly.
The American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) continues to review currently available resources and recommendations from the most reputable sources of healthcare information to guide physicians who treat patients with neuromuscular disorders.
Visit the AANEM website for the latest guidance regarding COVID-19
