Regulatory Approval Details

The approval includes:

  • Two new dosage strengths: 62 mg and 83 mg capsules
  • Expansion of indications to cover symptomatic treatment of myotonia in children (6–11 years, weighing at least 20 kg), adolescents (12–17 years), and adults (≥18 years) with non-dystrophic myotonic disorders
  • This adds to the existing 167 mg strength formulation

Product Significance

NaMuscla is the only antimyotonic agent licensed to treat symptomatic myotonia in non-dystrophic myotonic disorders in Europe. The drug works by reducing skeletal muscle hyperexcitability through its use-dependent, voltage-gated, sodium channel blocking actions.

Clinical Background

Non-dystrophic myotonias (NDM) are rare inherited neuromuscular disorders with a prevalence of approximately 1:100,000. These disorders are characterized by myotonia - an inability to relax skeletal muscle contractions that affects daily activities such as walking, climbing stairs, and hand movements. The condition typically begins in childhood and persists throughout the patient's lifetime.

Management Commentary

Claus Jepsen, President, Global Specialty at Lupin, stated: "This EMA approval for Pediatric Indication of NaMuscla represents a significant step forward for patients and families living with non-dystrophic myotonic disorders—especially children, where options are scarce. At Lupin, we remain committed to broadening access to therapies that improve outcomes across every stage of care."

Implementation Plan

Lupin is now working towards making the new dosage strengths and expanded pediatric indication available across Europe, subject to:

  • Local implementation timelines
  • National reimbursement processes
  • Access processes in individual European markets

Company Background

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin operates 15 manufacturing sites and 7 research centers globally with over 24,000 professionals.

Safety Profile

According to clinical trials referenced in the announcement, NaMuscla (167 to 500 mg/day) has been shown to significantly reduce myotonia compared to placebo, with gastro-intestinal discomfort reported as the most common adverse event. The drug has demonstrated safety and tolerability in clinical studies.