Lupin has announced that the European Medicines Agency (EMA) has approved a change to the terms of Marketing Authorisation (MA) for NaMuscla, supported by the Pediatric Investigation Plan (PIP). The approval includes 2 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 toward making new dosage strengths and expanded pediatric indication available across Europe, subject to local implementation timelines and national reimbursement and access processes.