The approval, supported by the Pediatric Investigation Plan (PIP), includes two new capsule strengths of 62 mg and 83 mg, in addition to the existing 167 mg dosage.
It also expands the approved indication to include the symptomatic treatment of myotonia in children aged 6-11 years weighing at least 20 kg, adolescents aged 12-17 years, and adults with non-dystrophic myotonic disorders.
Lupin said it is now working to make the new dosage strengths and the expanded pediatric indication available across Europe, subject to local implementation timelines as well as national reimbursement and market access processes.
Commenting on the development, 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.”
About non-dystrophic myotonic disorder
Non-dystrophic myotonias are a group of rare inherited neuromuscular disorders characterised by myotonia, a condition in which muscles are unable to relax properly after voluntary contraction. The disorder typically begins in childhood and can persist throughout a patient’s lifetime, often affecting mobility and daily activities. The expanded approval is expected to improve treatment access for pediatric patients with the rare condition across Europe.
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