Global pharmaceutical company Lupin Limited has received approval from the European Medicines Agency (EMA) to expand the marketing authorization for NaMuscla®, enabling its use in pediatric patients with non-dystrophic myotonic disorders (NDM). The approval also introduces two new capsule strengths, broadening treatment options for patients across different age groups and body weights.
NaMuscla® remains the only approved therapy in Europe for the symptomatic treatment of myotonia associated with non-dystrophic myotonic disorders, a group of rare neuromuscular conditions characterized by delayed muscle relaxation after contraction. The latest EMA approval follows the successful completion of the Pediatric Investigation Plan (PIP) and extends the product’s indication to include children aged 6 to 11 years weighing at least 20 kilograms, adolescents aged 12 to 17 years, and adults aged 18 years and above.
As part of the expanded authorization, Lupin will introduce two additional dosage strengths—62 mg and 83 mg capsules—which will complement the existing 167 mg formulation. The availability of multiple strengths is expected to support more individualized dosing, particularly for younger patients, helping physicians tailor treatment according to age and body weight.
Commenting on the development, Claus Jepsen, President, Global Specialty, Lupin, said the approval marks an important advancement for patients living with non-dystrophic myotonic disorders, particularly children who have had limited treatment options. He noted that the expanded indication reflects the company’s commitment to improving access to therapies that address unmet medical needs and enhance patient care across all stages of treatment.
Lupin has initiated preparations to introduce the new dosage strengths and expanded pediatric indication across European markets. The rollout will take place in accordance with country-specific implementation timelines, reimbursement procedures and market access approvals. The approval strengthens Lupin’s presence in the rare disease and specialty pharmaceuticals segment, reinforcing its focus on developing and commercializing therapies that address complex medical conditions with limited treatment alternatives.
Headquartered in Mumbai, Lupin is one of the world’s leading pharmaceutical companies, with a presence in more than 100 countries. Its portfolio spans branded and generic medicines, complex generics, biotechnology products and active pharmaceutical ingredients, serving patients across a wide range of therapeutic areas including respiratory diseases, cardiovascular care, diabetes, anti-infectives, gastroenterology, central nervous system disorders and women’s health.
The company operates 15 manufacturing facilities and seven research centres worldwide, supported by a workforce of over 24,000 employees. Through its businesses in diagnostics, digital health and pharmaceutical manufacturing solutions, Lupin continues to expand its healthcare ecosystem while advancing its mission of improving patient outcomes through innovation, quality and global access to medicines.
