Namuscla recommended by NICE for treatment of myotonia in adults with NDM: Lupin

Slough: Global pharma major Lupin has recently announced that the National Institute for Health and Care Excellence (NICE) has issued the Final Appraisal Determination (FAD) recommending the routine funding of Namuscla (mexiletine) in England and Wales.

NICE recommends Namuscla (mexiletine) within its marketing authorisation, as an option for treating the symptoms of myotonia in adults with non-dystrophic myotonic disorders. Lupin has agreed a confidential patient access scheme with NHS England (NHSE). 

NDM is a group of rare genetic neuromuscular disorders caused by mutations in sodium or chloride ion channels,  affecting approximately 400 patients in England. Clinically, NDM manifests with myotonia, a muscle stiffness which makes it difficult to perform daily activities. Myotonia can severely affect different parts of the body with pain, weakness and fatigue being the main symptoms, among others, that accompany the disease. 

Namuscla is licensed in the European Union and the UK for the symptomatic treatment of myotonia in adults with NDM. 

"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," said Ben Ellis, General Manager of Lupin Healthcare UK. "Lupin's transformational journey into specialty disease areas continues, with future investments planned for neuromuscular diseases, to meet unmet patient need."

Lupin provided comprehensive data to support the NICE submission, demonstrating the efficacy and longterm safety of Namuscla and the significant improvements in the quality of life for NDM patients. Supporting evidence included three randomised controlled studies and two retrospective long-term studies.

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