One of India's Largest Pharmaceutical Companies Receives EMA Approval to Expand NaMuscla Indication to Children with Two New Dosage Strengths

On Wednesday, Indian benchmark indices traded higher, with the Nifty 50 rising 140.10 points, or 0.59 per cent, to 24,005.85. Despite the positive market sentiment, shares of Lupin Limited declined 0.89 per cent to Rs 2,397.50. The stock touched an Intraday high of Rs 2,443.40 and a low of Rs 2,392.00. Trading activity remained below average, with 4.71 lakh shares changing hands compared with the 30-day average volume of 9.52 lakh shares.

EMA Expands NaMuscla Approval

Lupin Limited announced that the European Medicines Agency (EMA) has approved a variation to the marketing authorisation of NaMuscla, its treatment for symptomatic myotonia associated with non-dystrophic myotonic disorders (NDM).

Supported by the Paediatric Investigation Plan (PIP), the approval expands the product's indication to include children aged 6 to 11 years weighing at least 20 kg and adolescents aged 12 to 17 years, in addition to the existing approval for adults aged 18 years and above.

Two New Dosage Strengths Approved

As part of the approval, the EMA has also authorised two new capsule strengths of 62 mg and 83 mg, alongside the existing 167 mg dosage.

Lupin said it is working towards making the expanded paediatric indication and new dosage strengths available across Europe, subject to country-specific implementation timelines, reimbursement approvals and market access processes.

About Non-Dystrophic Myotonic Disorders

Non-dystrophic myotonias are rare inherited neuromuscular disorders affecting approximately 1 in 100,000 people. The condition is caused by mutations in skeletal muscle ion channels, resulting in myotonia, where muscles fail to relax normally after voluntary movement.

Symptoms typically begin during childhood and may include muscle stiffness, cramps, pain and difficulty releasing grip, significantly affecting patients' quality of life. Due to the rarity of the disease, diagnosis is often delayed and treatment options for children have remained limited.

Management Commentary

Commenting on the approval, Claus Jepsen, President – Global Specialty, Lupin, said: "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."

About Lupin

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, with operations across more than 100 countries. The company has a diversified portfolio spanning branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients (APIs). It operates 15 manufacturing facilities and seven research centres worldwide and employs more than 24,000 professionals.
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Disclaimer: The article is for informational purposes only and not investment advice.