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The agency approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients six to less than 17 years of age.
On May 6, 2019, FDA announced that it had approved the first treatment for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder, in pediatric patients age six to less than 17. FDA granted the application by Jacobus Pharmaceutical Company, Inc. Priority Review, Fast Track, and Orphan Drug designations.
The approval of the use of Ruzurgi in pediatric patients was determined by studies in adults with LEMS, pharmacokinetic data in adult patients, pharmacokinetic modeling, and simulation to identify the dosing regimen in pediatric patients. Common side effects of Ruzurgi seen in pediatric patients include a burning or prickling sensation, abdominal pain, indigestion, dizziness, and nausea.
LEMS causes the body’s immune system to attack the connection between nerves and muscles and disrupts the signals between muscle nerve and muscle cells, according to FDA. LEMS may also precede or coincide with a diagnosis of cancer.