Lupin Neurosciences, a specialty pharma division of Lupin Ltd, said that the Committee for Medicinal Products for Human Use or CHMP, the scientific committee of the European Medicines Agency or 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 or 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. 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 earlier been awarded an Orphan Drug designation.
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.
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