EC Approved Indian Orphan Drug

| By | CHMP, European Commission, Indian Pharma, Lupin, Orphan Drugs

The European Commission (EC) has approved NaMuscla (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders from Indian drugmaker Lupin.

Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes.

Lupin has partnering discussions ongoing for commercialization of NaMuscla in European territories outside Germany and the UK.

The EC approval follows the positive opinion which was issued by the Committee for Medicinal Products for Human Use (CHMP) in October 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein. The approval makes NaMuscla, which recently had its orphan drug designation ratified by the European Medicines Agency’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.

Lupin is preparing for the launch of NaMuscla, which will occur in the initial markets of Germany and the UK in first-quarter 2019.

Thierry Volle, president of EMEA Lupin, commented: “The EC approval represents a further important milestone for Lupin as we build 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.

SOURCE: The Pharma Letter
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