Lupin Neurosciences, a specialty pharma division of Lupin, announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMuscla™ (mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability of muscle relaxation following voluntary contraction. NaMuscla™ reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes.
The CHMP's positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The EC decision is expected within three months and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein. If approved, NaMuscla™ will be the first treatment licensed throughout the EU for the symptomatic treatment of myotonia in adults with NDM disorders. The therapy had already been awarded Orphan Drug designation.
''With this positive CHMP opinion we are now one step closer to offering NaMuscla™ to patients with non-dystrophic myotonia, for whom there are currently no licensed treatment options available across all EU countries,'' said Thierry Volle, President EMEA, Lupin. ''We eagerly await the next step; namely the European Commission's decision, but the positive opinion represents an important milestone for Lupin Neurosciences as we build a leading specialty pharma company focused on the development, registration and commercialization of science-based therapies and solutions for neurological disorders that can restore function and significantly improve lives.''
Shares of the company gained Rs 11.75, or 1.34%, to trade at Rs 889.35. The total volume of shares traded was 11,180 at the BSE (9.39 a.m., Monday).
