Lupin's NaMuscla Gains EMA Approval for Pediatric Use

Lupin Limited announced that the European Medicines Agency (EMA) has approved an expansion of marketing authorization for NaMuscla. This approval includes two new dosage strengths (62 mg and 83 mg capsules) and extends the indication to cover symptomatic treatment of myotonia in children (6-11 years, weighing at least 20 kg), adolescents (12-17 years), and adults (≥18 years) with non-dystrophic myotonic disorders. NaMuscla is the only approved treatment for myotonia symptoms in NDM in Europe. Lupin is working to make these new strengths and the expanded pediatric indication available across Europe, subject to local timelines and reimbursement processes. This development is significant for patients, especially children, who have limited treatment options.