Lupin gets EMA approval for NaMuscla pediatric expansion with new strengths

Regulatory Product ApprovalBusiness Updates View source PDF

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AI summary

Lupin announced European Medicines Agency (EMA) approval to expand NaMuscla, its treatment for non-dystrophic myotonic disorders (NDM), to children aged 6 to 11 years (weighing at least 20 kg), alongside adolescents and adults. The approval, supported by the Pediatric Investigation Plan, also adds two new dosage strengths of 62 mg and 83 mg capsules to the existing 167 mg. NaMuscla remains the only approved treatment for myotonia symptoms in NDM in Europe. Lupin will roll out the new strengths and expanded indication across Europe subject to local reimbursement timelines.

Likely market impact

Positive for Lupin's specialty business. Expands addressable patient base in Europe and strengthens its rare disease portfolio.