Lupin and Exeltis announce reimbursement approval of NaMuscla

Agreement enables sustainable patient access of the only EU-approved treatment for myotonia symptoms

Lupin and Exeltis Healthcare announced yesterday that the Spanish Ministry of Health (MSCBC) has approved the reimbursement of Lupin’s NaMuscla (mexiletine) for the symptomatic treatment of myotonia in adults with Non-Dystrophic Myotonic (NDM) disorders on the National Health and Pharmacy Service. NaMuscla is the first and only licensed product for this indication in Europe and will be commercialised by Lupin’s partner Exeltis in Spain, a statement from Lupin has notified.

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. It has been designated Orphan Drug Status (ODS) and received EU marketing authorisation in December 2018, the statement said.

Lupin’s paediatric trial (NCT04624750), part of the paediatric investigation plan for NaMuscla in children with myotonic disorders, is ongoing and successfully concluded patient enrollment in a first patient cohort group who were offered and rolled over into a two-year follow-up study (NCT04622553). A post-authorisation study to address long-term safety and treatment effects of NaMuscla on patient-reported outcomes in adults with NDM (NCT04616807) has concluded patient enrollment and will provide three years prospective data on NaMuscla in a real-life setting, the statement concluded.

Exeltis HealthcareLupinNaMusclaOrphan Drug Statuspaediatric trialreimbursement approval
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