European Medicines Agency OKs marketing Lupin's NaMuscla for paediatric use
This story was originally published at 18:36 IST on 1 July 2026
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--Lupin: European Medicines Agency OKs NaMuscla sales for pediatric dosages
MUMBAI – Lupin Ltd. Wednesday said the European Medicines Agency has approved a change to the marketing authorisation for its NaMuscla drug. The approval was supported by the Pediatric Investigation Plan which has now allowed the company to market two new dosage strengths, 62 milligrams and 83 milligrams capsules, alongside the existing 167 milligrams. The revised indications cover the symptomatic treatment of myotonia in children aged six to 11 years, weighing at least 20 kilograms, adolescents aged 12 to 17 years, and adults aged 18 years or above with non-dystrophic myotonic disorders, according to an exchange filing.
Myotonia is an inability to relax a contraction of skeletal muscle, which originates from a voluntary muscular contraction such as shaking someone's hand, blinking, or other everyday activities. In randomised controlled trials, NaMuscla dosages ranging from 167 milligrams to 500 milligrams per day have been shown to significantly reduce myotonia compared to placebo, thereby reducing skeletal muscle hyperexcitability through its use-dependent, voltage-gated, and sodium channel-blocking actions, which are independent of the cause of channel function, Lupin said.
For the quarter ended March, Lupin had reported a consolidated net profit of INR 14.60 billion on revenues of INR 74.75 billion. Wednesday, its shares ended at INR 2,397.50 apiece on the National Stock Exchange, down slightly from Tuesday. End
Reported by Eshitva Prakash
Edited by Himanshi Gupta
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