Lupin Neurosciences Announces Positive CHMP Opinion for NaMuscla™ for the Treatment of Myotonia in Non-Dystrophic Myotonic Disorders
Deepthi | Myequity news | Date : 19-10-2018 18:30:00 IST
Lupin Neurosciences, a specialty pharma division of Lupin Ltd, announced 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.”
The positive opinion from the CHMP was based on a pivotal Phase III clinical study (MYOMEX1) which enrolled 25 participants who were diagnosed with non-dystrophic myotonic disorders and symptomatic myotonia, in addition to bibliographical references, including three controlled clinical studies, to support the efficacy and safety of mexiletine.
About Lupin Neurosciences:
Lupin Neurosciences is a division of Lupin Ltd. It is committed to improving the lives of patients affected by underserved neurological disorders. Its mission is to expand patient access to science-based therapies and solutions through building a global portfolio of specialty pharmaceuticals for development, registration and commercialization with partners and collaborators. About Lupin Limited:
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.