Jacobus Pharmaceutical’s Ruzurgi (amifampridine) Receives the US FDA’s Approval for Lambert-Eaton myasthenic syndrome

Shots:

• The approval is based on the study assessing Ruzurgi vs PBO in 32 adult patients while patients taking Ruzurgi for at least three months prior to entering the study
• The study measured effectiveness of a patient to rise from a chair, walk three meters & return to the chair for three consecutive laps without pause, self-assessment scale for LEMS-related weakness evaluating the feeling of weakening or strengthening which was more in PBO patients and patients experienced less impairment vs PBO
• Ruzurgi tablets is a potassium chain blocker indicated for LEMS and has received FDA’s Priority Review and Fast Track designation as well as Orphan Drug Designations

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