Drug major Lupin Tuesday 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.
Shares of Lupin were trading 0.68 per cent higher at Rs 826.50 apiece on BSE.
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.