LUPIN EXPANDS NAMUSCLA INDICATION IN EUROPE

• 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. • Revised indications 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 towards making new dosage strengths and expanded pediatric indication available across Europe, subject to local implementation timelines and national reimbursement and access processes.

Lupin Limited

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