Lupin Limited announced that the European Medicines Agency (EMA) has approved a change to the marketing authorization for NaMuscla®, supported by a Pediatric Investigation Plan (PIP), adding two new dosage strengths to the existing 167 mg capsule.
The approval adds 62 mg and 83 mg capsules to expand symptomatic treatment of myotonia in children aged 6 to 11 years weighing at least 20 kg, adolescents aged 12 to 17 years, and adults with non-dystrophic myotonic disorders.
NaMuscla remains the only approved treatment for myotonia symptoms in non-dystrophic myotonic disorders in Europe, with clinical trials at doses of 167 to 500 mg/day showing significant reduction in myotonia and improved quality-of-life outcomes.
Non-dystrophic myotonic disorders are rare inherited neuromuscular conditions with a prevalence of about 1 in 100,000, affecting muscle relaxation and daily activities in patients who experience increasing symptom severity over time.
Lupin is now proceeding with making the new strengths and expanded pediatric indication available across Europe, subject to local implementation timelines and national reimbursement and access processes.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with 15 manufacturing sites and 7 research centers globally, serving over 100 markets with a workforce of more than 24,000 professionals.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.