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Global pharma major Lupin Ltd. has received approval from the Spanish Health Ministry for the reimbursement of NaMuscla (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic disorders.

Myotonia is a neuromuscular condition that affects the relaxation of muscles, and the symptoms include fatigue, stiffness of muscles, and abnormal appearance of muscles, among others.

NaMuscla is the first and only licensed product for the symptomatic treatment of non-dystrophic myotonic (NDM) disorder in Europe and will be commercialised by Lupin’s partner Exeltis in Spain.

The filing mentioned that the decision on reimbursement will aid the company to distribute NaMuscla quickly and effectively, and strengthen its position in the central nervous system area.

Lupin’s transformational journey into specialty disease areas continues, with future investments planned for neuromuscular diseases, to meet the unmet needs of patients.

Non-dystrophic myotonic (NDM) disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 1,00,000 inhabitants in Spain.

NaMuscla reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients.

NaMuscla, which has been designated orphan drug status, received EU marketing authorisation in December 2018.

Lupin also said that to date, people in Spain living with NDM have had limited access to a licensed treatment for myotonia that can reduce the daily burden of this disabling, lifelong condition.

Lupin’s pediatric trial, part of the pediatric investigation plan for NaMuscla in children with myotonic disorders, is ongoing and successfully concluded patient enrolment in a first-patient cohort group who were offered and rolled over into a 2-year follow-up study.

Mumbai-based Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets globally.

Shares of Lupin are trading 0.89 percent higher at Rs 756.50.

(Edited by : Rukmani Krishna)