Lupin announces EMA approval for NaMuscla expansion for pediatric indication with new strengths

NaMuscla is the only approved treatment for myotonia symptoms in NDM in Europe

Global pharma major Lupin Limited (Lupin) announced that the European Medicines Agency (EMA) has approved a change to the terms of marketing authorization for NaMuscla, supported by the Pediatric Investigation Plan (PIP). The approval includes two new dosage strengths, 62 mg and 83 mg capsules, in addition to the existing 167 mg, and the revised indications that 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.

Claus Jepsen, President, Global Specialty, Lupin, said, “This EMA approval for Pediatric Indication of NaMuscla represents a significant step forward for patients and families living with non-dystrophic myotonic disorders—especially children, where options are scarce. At Lupin, we remain committed to broadening access to therapies that improve outcomes across every stage of care.”

Lupin is now working towards making new dosage strengths and expanded pediatric indication available across Europe, subject to local implementation timelines and national reimbursement and access processes.