Lupin, Exeltis bag reimbursement approval for NaMuscla in Spain

10 Jan 2023 , 10:20 AM

Lupin Limited (Lupin) and Exeltis Healthcare S.L (Exeltis) announced that the Spanish Ministry of Health (MSCBC) has approved reimbursement of Lupin’s NaMuscla (mexiletine) on the National Health and Pharmacy Service. NaMuscla is prescribed for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. 

NaMuscla is Europe’s first and only licensed product for this indication, and it will be commercialized in Spain by Lupin’s partner Exeltis.

NDM disorders are a group of rare, inherited neuromuscular disorders that are characterized by the inability to relax muscles following voluntary contraction and have an estimated prevalence of 1 case per 100,000 inhabitants in Spain (myotonia).

NaMuscla relieves myotonia symptoms in people with NDM. NaMuscla received its EU marketing authorization in December 2018.

Lupin’s pediatric trial, which is part of the pediatric investigation plan for NaMuscla in children with myotonic disorders, is currently underway and has successfully completed patient enrolment in the first patient cohort group, which was offered and rolled over into a 2-year follow-up study, stated the company in its media release.

A post-authorization study to investigate the long-term safety and treatment effects of NaMuscla on patient-reported outcomes in adults with NDM has completed patient enrollment and will provide 3 years of prospective data on NaMuscla in a real-world setting.

At around 10.16 AM, Lupin was trading 1.29% higher at Rs759.55 apiece, against the previous close of Rs749.85 on NSE. The counter touched an intraday high and low of Rs762.75 and Rs750 respectively.

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