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.
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