Ruzurgi Approved for Pediatric Lambert-Eaton Myasthenic Syndrome (LEMS)

The FDA has approved Ruzurgi (amifampridine) tablets, the first approval specifically for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to under 17 years of age. Ruzurgi is a potassium-channel blocker.

LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms often affecting activities of daily living.

Pediatric use of the drug is supported by evidence from a placebo-controlled withdrawal study in 32 adults with LEMS that had taken the drug for at least 3 months. Results demonstrated less impairment in a test of walking.

Common side effects were similar to adults and included burning or prickling sensation (paresthesia), stomach pain, indigestion, dizziness and nausea.

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