Drug maker Lupin Saturday said the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of its product NaMuscla, used for the symptomatic treatment of non-dystrophic myotonic (NDM) disorders.
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, has adopted a positive opinion recommending the marketing authorisation of NaMuscla (mexiletine hydrochloride), Lupin said in a statement.
NaMuscla is a product of Lupin Neurosciences, a specialty pharma division of the company.
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 Mumbai-based firm added.
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.
"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.
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, the company said.