The European Commission (EC) has given go-ahead to NaMuscla, a myotonia treatment drug by Lupin.
NaMuscla is used for the symptomatic treatment of myotoniain adults with non-dystrophic myotonic (NOM) disorders, a group of rare, inherited, neuromuscular disorders which cause the inability to relax muscles following voluntary contraction.
In a BSE filing, the drug major said, “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.”
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 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.