Lupin said that the UK’ National Institute for Health and Care Excellence (NICE) has recommended Namuscla (mexiletine), an antimyotonic agent, for the approval of its use in the treatment of symptomatic myotonia in adults with non-dystrophic myotonic disorders (NDM).

The Indian pharma company, through its subsidiary — Lupin Healthcare (UK), has agreed to a confidential patient access scheme with NHS England (NHSE).

NICE’s recommendation is said to have been driven by the data provided by Lupin showing the efficacy and long-term safety of Namuscla and the considerable improvements in the quality of life for patients with non-dystrophic myotonic disorders. The evidence for this was supported by the findings of three randomized controlled studies and a couple of retrospective long-term studies, said Lupin.

Non-dystrophic myotonic disorders are a group of rare genetic neuromuscular disorders, affecting nearly 400 patients in England. The cause of the disorders is mutations in sodium or chloride ion channels.

Namuscla is licensed by Lupin in the UK and the European Union for the indication.

Ben Ellis — General Manager of Lupin Healthcare UK said: “We are delighted that NDM patients in England and Wales will be able to access Namuscla. We are grateful to patients, their caregivers and all the healthcare professionals involved in the NICE process. The decision by NICE is a significant step forward for patients with rare disease as well as for repurposing medicines.

“Lupin’s transformational journey into specialty disease areas continues, with future investments planned for neuromuscular diseases, to meet unmet patient need.”

  Ben Ellis, Lupin, Lupin Healthcare (UK), mexiletine, myotonia, Namuscla, National Institute for Health and Care Excellence, NHS England, NHSE, NICE, non-dystrophic myotonic disorders, United Kingdom