Lupin Announces EMA Approval for NaMuscla Pediatric Indication and New Dosage Strengths
Global pharmaceutical major Lupin Limited today announced that the European Medicines Agency (EMA) has approved a change to the terms of marketing authorization for its drug, NaMuscla. This approval includes the addition of two new dosage strengths—62 mg and 83 mg capsules—to the existing 167 mg strength.The expanded indication covers the symptomatic treatment of myotonia in various age groups with non-dystrophic myotonic disorders (NDM). The approved patient demographics include children aged 6 to 11 years weighing at least 20 kg, adolescents aged 12 to 17 years, and adults aged 18 years and above. NaMuscla is currently the only approved treatment for myotonia symptoms in NDM across Europe.
Claus Jepsen, President of Global Specialty at Lupin, stated that the EMA approval for the Pediatric Indication represents a significant step forward for patients and families living with non-dystrophic myotonic disorders, especially given the limited options available for children.
Lupin is now focused on making these new dosage strengths and the expanded pediatric indications available across Europe. This rollout remains subject to national reimbursement and access processes in each country.
The approval reflects the growing therapeutic use of NaMuscla (mexiletine), which has been shown in randomized controlled trials to significantly reduce myotonia compared to placebo, thereby improving patient quality-of-life and functional outcomes. The treatment is characterized by its ability to block voltage-gated, sodium channel actions, independent of the cause of channel function.
LUPIN Stock Price Movement
Shares of Lupin Limited slipped on Wednesday, concluding the session at ₹2397.5 after falling 0.90% from previous levels. The stock saw significant volume with 470,880 shares traded and closed within a day range defined by a low of ₹2392 and a high of ₹2443.4.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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