The approval makes NaMuscla (mexiletine) the first treatment to be licensed throughout the EU for the symptomatic treatment of myotonia in adults with NOM disorders
Lupin said the European Commission (EC) has approved its product NaMuscla, used for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NOM) disorders. Non-dystrophic myotonic disorders are a group of rare, inherited, neuromuscular disorders which cause the inability to relax muscles following voluntary contraction.
“The EC approval follows the positive opinion which was issued by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), in October 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein,” Lupin said in a BSE filing.
The approval makes NaMuscla (mexiletine) the first treatment to be licensed throughout the EU for the symptomatic treatment of myotonia in adults with NOM disorders, the company added. Lupin said it has ongoing partnering discussions for commercialisation of NaMuscla in European territories outside Germany and the UK.
Lupin said it is preparing for the launch of NaMuscla, which will occur in the initial markets of Germany and the UK in the first quarter of 2019. The approval was based on a pivotal Phase III clinical study (MYOM EX1) which enrolled 25 participants who were diagnosed with non-dystrophic myotonic disorders and symptomatic myotonia, in addition to bibliographical references, the company said.
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