According to reports from CNBC TV18, Lupin announced that the European Medicines Agency (EMA) has approved an expansion of the marketing authorization for NaMuscla, allowing its use in pediatric patients with non-dystrophic myotonic disorders (NDM). The approval is supported by the Pediatric Investigation Plan (PIP) and represents a significant expansion of the drug's therapeutic applications across Europe. As per Lupin's latest announcement, this regulatory approval represents a significant step forward for patients and families living with non-dystrophic myotonic disorders—especially children, where options are scarce. The approval addresses an unmet medical need for pediatric patients with rare muscle disorders and validates Lupin's commitment to the orphan drug space. Commenting on the approval, Claus Jepsen, President – Global Specialty, Lupin, stated: "The EMA approval for the paediatric indication of NaMuscla represents a significant step forward for patients and families living with non-dystrophic myotonic disorders, particularly children where therapeutic options remain scarce. We remain committed to broadening access to therapies that improve outcomes across every stage of care."
As reported by CNBC TV18, the approval includes two new dosage strengths, 62 mg and 83 mg capsules, in addition to the existing 167 mg capsule. This expansion provides healthcare professionals with more treatment options for patients across different weight categories and age groups, with the new dosage strengths now available across Europe subject to local implementation timelines and national reimbursement processes. NaMuscla is now the only antimyotonic agent licensed to treat symptomatic myotonia in children aged 6 to 11 years weighing at least 20 kg, adolescents aged 12 to 17 years, and adults over 18 years with non-dystrophic myotonic disorders. The addition of 62 mg and 83 mg strengths allows for precise weight-based dosing required for children and adolescents, ensuring that pediatric patients receive the exact therapeutic levels required while minimizing the risk of side effects.
According to CNBC TV18, the revised indications cover symptomatic treatment of myotonia in children (6-11 years, weighing at least 20 kg), adolescents (12-17 years), and adults with non-dystrophic myotonic disorder. Non-dystrophic myotonias are a group of rare inherited neuromuscular disorders characterized by myotonia, a condition where 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. In randomised controlled trials, NaMuscla has been shown to significantly reduce myotonia compared to placebo, improving patient quality of life and other functional outcomes. NaMuscla (mexiletine) is indicated for the symptomatic treatment of non-dystonic myotonia, a rare genetic muscle disorder characterized by the inability of muscles to relax after contraction. The drug works through use-dependent, voltage-gated, sodium channel blocking actions which are independent of the cause of channel function, reducing skeletal muscle hyperexcitability and improving patient outcomes.
As reported by CNBC TV18, this regulatory approval represents a significant expansion of NaMuscla's therapeutic reach in the European market. Lupin is now working to make 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. At Lupin, we remain committed to broadening access to therapies that improve outcomes across every stage of care, as stated by Claus Jepsen, President of Global Specialty at Lupin. The EMA expansion typically leads to a 10-15% increase in the addressable market for specialty orphan drugs, and this regulatory win underscores Lupin's strategy of pivoting toward complex generics and specialty products. The approval is expected to have a positive impact on Lupin's European revenue mix, with the high per-unit pricing and lack of competition providing significant margin support. By securing pediatric approval, Lupin effectively blocks competitors from entering with off-label or non-licensed versions of the drug for children, reinforcing its status as the sole licensed provider of mexiletine in the EU.
Despite the positive regulatory news, Lupin's stock performance showed mixed results on Wednesday. According to market data, Lupin Limited shares declined 0.89% to ₹2,397.50 despite the positive market sentiment, with the Nifty 50 rising 140.10 points, or 0.59% to 24,005.85. The stock touched an intraday high of ₹2,443.40 and low of ₹2,392.00, while trading activity remained below average with 4.71 lakh shares changing hands compared with the 30-day average volume of 9.52 lakh shares. The muted stock response may reflect broader market conditions or investor expectations for the drug's commercial rollout timeline across Europe.
