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Lupin, Exeltis bag reimbursement approval for NaMuscla in Spain
IMT News Desk -
1 year ago
Lupin, Exeltis bag reimbursement approval for NaMuscla in Spain
IMT News Desk -
1 year ago
NaMuscla is Europe's first and only licensed product for this indication, and it will be commercialised in Spain by Lupin's partner Exeltis
Lupin and Exeltis Healthcare (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 commercialised in Spain by Lupin's partner Exeltis.
NDM disorders are a group of rare, inherited neuromuscular disorders that are characterised by the inability to relax muscles following voluntary contraction and have an estimated prevalence of one case per 100,000 inhabitants in Spain (myotonia).
NaMuscla relieves myotonia symptoms in people with NDM. NaMuscla received its EU marketing authorisation in December 2018.
Lupin's paediatric trial, which is part of the paediatric investigation plan for NaMuscla in children with myotonic disorders, is currently underway and has completed patient enrollment in the first patient cohort group, which was offered and rolled over into a two-year follow-up study, stated the company in its media release.
A post-authorisation 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 three years of prospective data on NaMuscla in a real-world setting.