Lupin Gets EMA Approval to Expand NaMuscla Use for Children with Rare Muscle Disorder
New Delhi: Lupin Limited has received approval from the European Medicines Agency (EMA) for a variation to the marketing authorisation of NaMuscla (mexiletine), expanding its use to include children with non-dystrophic myotonic disorders (NDM) and adding two new dosage strengths.
According to the company, the approval is supported by the Pediatric Investigation Plan (PIP) and includes two new capsule strengths—62 mg and 83 mg—in addition to the existing 167 mg formulation.
The revised marketing authorisation also expands the indication of NaMuscla for the symptomatic treatment of myotonia in children aged 6–11 years weighing at least 20 kg, adolescents aged 12–17 years, and adults aged 18 years and above with non-dystrophic myotonic disorders.
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."
Lupin said it is now working towards making the new dosage strengths and expanded pediatric indication available across Europe, subject to local implementation timelines as well as national reimbursement and market access processes.
Non-dystrophic myotonic disorders are rare inherited neuromuscular disorders characterised by myotonia, a condition in which muscles are unable to relax properly after voluntary contraction. Symptoms typically begin in childhood and can affect daily activities such as walking, climbing stairs, gripping objects and swallowing. The disorders are caused by mutations affecting sodium or chloride ion channels in skeletal muscle and can significantly impact patients' quality of life.
According to Lupin, NaMuscla is currently the only licensed antimyotonic therapy indicated for the symptomatic treatment of myotonia in children aged 6 to 11 years weighing at least 20 kg, adolescents and adults with non-dystrophic myotonic disorders. Clinical studies have demonstrated that the medicine significantly reduces myotonia compared with placebo, improving muscle function and patient quality of life, while gastrointestinal discomfort has been reported as the most common adverse event.
