Lupin gets first EU licensed treatment in EU for myotonia in adults, hits UK German markets in Q1 2019

Lupin got the EC approval of NaMuscla for reducing myotonia symptoms in adult patients, and has partnering discussions ongoing for commercialization of NaMuscla in European territories outside Germany and the UK.

Professor Christiane Schneider-Gold of Germany’s Bochum St. Josef und St. Elisabeth Hospital / Neurologische Universitätsklinik said that the approval and commercialization of NaMuscla brings to an end the difficult off-label treatment challenges faced by these patients. She added that with no licensed antimyotonic drug being available to date, many patients have lived without treatment. In a statement provided by Lupin, she said: “NaMuscla fills an important, unmet clinical need for a licensed, efficacious treatment with a positive risk-benefit profile which is proven to significantly improve patient quality-of-life and disability caused by myotonia’s lifelong impact.”

Lupin has reported Tuesday that the European Commission (EC) has approved NaMuscla (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. The company noted in the announcement that non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction.

The approval makes NaMuscla, which recently had its orphan drug designation ratified by the EMA’s Committee for Orphan Medicinal Products (COMP), the first treatment to be licensed throughout the EU for the symptomatic treatment of myotonia in adults with NDM disorders.

Initial markets Germany and the UK

Lupin said it will first launch NaMuscla in the markets of Germany and the UK in Q1 2019.

Thierry Volle, President EMEA, Lupin said that the EC approval represents a further important milestone for Lupin as the company builds a leading specialty pharma company focused on the development, registration and commercialization of science-based therapies and solutions for areas of unmet medical need. “We are now closer to being able to provide patients with an effective treatment for myotonia symptoms and we look forward to launching the product in the first territories in Q1 2019.”

Lupin-found data show that more than 7500 people in Europe living with NDM have limited access to a licensed treatment for myotonia which reduces the daily burden of this disabling, lifelong symptom. Limited access leads to inconsistent medication supply, administrative challenges and associated financial burdens, which, along with low awareness and clinical experience among healthcare professionals, may result in harm to patients. Lupin added it is also pursuing a paediatric investigation plan (PIP) for NaMuscla.