FDA Approves Jacobus’ Ruzurgi As Pediatric Treatment for LEMS

The FDA approved Jacobus Pharmaceuticals’ Ruzurgi (amifampridine)  as a treatment for the rare neuromuscular disorder Lambert-Eaton myasthenic syndrome (LEMS) in children.

The approval came amid public outrage after the agency granted exclusive rights to Catalyst Pharmaceuticals for Firdapse, its version of the drug, for treatment of adult LEMS patients—and the company set the list price at $375,000 a year.

The FDA approval of Ruzurgi for pediatric use means that doctors will be able to prescribe Jacobus’ version of the treatment for all patients, but adults could be prescribed off-label.