Latest news with #FIRDAPSE
Yahoo
07-08-2025
- Health
- Yahoo
Lambert Eaton Myasthenic Syndrome (LEMS) Antibody Testing and Treatment Recommendations Added to NCCN Clinical Practice Guidelines for Small Cell Lung Cancer (SCLC)
VGCC antibody testing in conjunction with neurologic consultation can diagnose LEMS Amifampridine may be considered as a supportive care treatment Guideline inclusion may raise clinical awareness of cancer-associated LEMS to support broader VGCC diagnostic testing and treatment adoption CORAL GABLES, Fla., Aug. 06, 2025 (GLOBE NEWSWIRE) -- 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 the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Cell Lung Cancer (SCLC) now include new additions involving Lambert Eaton myasthenic syndrome (LEMS), amifampridine (FIRDAPSE®), and the tests for PQ- and N-type voltage-gated calcium channel (VGCC) antibodies. The updated NCCN Clinical Practice Guidelines in Oncology for SCLC relating to LEMS now include symptom specificity—characterized by proximal muscle weakness and autonomic dysfunction. Under 'Signs and Symptoms of Small Cell Lung Cancer' (SCL-A 2 of 2), the guidelines recommend diagnosis through a neurological evaluation, ideally in consultation with a neurologist, which may include testing for PQ- and N-type VGCC antibodies. Additionally, under 'Principles of Supportive Care' (SCL-D), the guidelines recommend that amifampridine should be considered as a treatment in consultation with neurology.1 Approximately 50 percent of LEMS cases are associated with an underlying malignancy, most commonly SCLC. Literature suggests that LEMS is observed in 3 percent of SCLC patients. Based on an internal healthcare database analysis of SCLC claims, potentially 90 percent of LEMS patients with SCLC went undiagnosed. These undiagnosed LEMS patients may suffer from LEMS symptoms while undergoing treatment for SCLC. 'Early diagnosis of LEMS in SCLC is critical, as it may enable patients to have better outcomes if their LEMS symptoms are effectively treated while fighting SCLC. Accurate identification through VGCC antibody testing and comprehensive neurological evaluation is essential,' said William Andrews, MD, FACP, Chief Medical Officer, Catalyst. 'The NCCN Guidelines are a trusted standard for guiding treatment decisions, and we believe this update will drive greater awareness. Ultimately, it will help patients, caregivers, and healthcare providers make more informed choices when addressing this serious unmet need.' 1NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. To learn more about NCCN go to About Catalyst PharmaceuticalsCatalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies. For more information, please visit Catalyst's website at Forward-Looking StatementsThis press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. 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 2024 and its subsequent 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. Source: Catalyst Pharmaceuticals, Inc. CONTACT: Investor Contact Mary Coleman, Catalyst Pharmaceuticals, Inc. (305) 420-3200 ir@ Media Contact David Schull, Russo Partners (858) 717-2310 in to access your portfolio
Cision Canada
18-06-2025
- Business
- Cision Canada
Kye Pharmaceuticals Receives Health Canada Approval for New Dosing Guidance for FIRDAPSE ® and an additional Pediatric Indication Français
MISSISSAUGA, ON, June 18, 2025 /CNW/ - Kye Pharmaceuticals, Inc. ("Kye") today announced that Health Canada has approved its SNDS (Supplemental New Drug Submission) regarding the recommended dosage of FIRDAPSE® (amifampridine) for adults to include that some patients may benefit from a total daily dose of 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). The direction that some patients may benefit from an increased maximum daily dose of up to 100 mg offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS. The expanded indication includes pediatric dosing guidance for patients 6 years of age and older and offers pediatric neurologists a proven treatment option for children diagnosed with 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 and works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, which helps improve muscle function in people with LEMS. This approval expands the approved dosing options for prescribers treating LEMS as well as broadening the indication to include pediatric patients. "We are pleased to receive the approval for both the additional guidance that some patients may benefit from an increased maximum daily dose of FIRDAPSE as well as the pediatric indication starting at age six," said John McKendry, President and CEO of Kye Pharmaceuticals. "This expanded label highlights our continued commitment to the LEMS community in Canada. We believe that this label update will have meaningful impact on the lives of LEMS patients across Canada and will help to improve patient outcomes." About Kye Pharmaceuticals Kye Pharmaceuticals is a growth-stage Canadian specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that may not otherwise be available to patients across Canada. With a growing pipeline of novel medicines, Kye's portfolio spans a range of therapeutic areas, including cardiology, psychiatry, pediatrics, rare diseases, hematology, and neurology. Kye Pharmaceuticals is a private company headquartered in Toronto focused on bringing medications to the Canadian market which fulfill clinically significant unmet needs. Kye is committed to licensing and launching medicines that matter by delivering better outcomes to our partners, Canadian healthcare professionals, and, most importantly, patients across Canada.
