Lupin and Exeltis Approve Reimbursement of NaMuscla® in Spain Key Points:
- Lupin Limited has received approval from the Spanish Ministry of Health for the reimbursement of NaMuscla® for the treatment of myotonia in adults with non-dystrophic myotonic disorders.
- NaMuscla® is the first and only licensed product for this indication in Europe and is developed in partnership with Exeltis Healthcare.
- NaMuscla® is used to treat non-dystrophic myotonic disorders, which are rare inherited neuromuscular conditions that cause muscles to remain tense after voluntary contractions.
- The approval of NaMuscla® in Spain will improve access to treatment for patients with non-dystrophic myotonic disorders, which has previously been limited.
- Lupin is currently conducting a pediatric trial for NaMuscla® and a post-authorization study to assess the long-term safety and treatment effects of the drug on patient-reported outcomes in adults with non-dystrophic myotonic disorders.
Lupin and Exeltis Approve Reimbursement of NaMuscla® in Spain News In Detail
Lupin Limited, a global pharmaceutical company, has received approval from the Spanish Ministry of Health for the reimbursement of NaMuscla® for the treatment of myotonia in adults with non-dystrophic myotonic disorders. This is the first and only licensed product for this indication in Europe. NaMuscla®, developed in partnership with Exeltis Healthcare S.L, will be distributed in Spain by Exeltis.
Lupin’s NaMuscla® has been approved for the treatment of non-dystrophic myotonic (NDM) disorders in Spain, making it the first and only licensed product for this indication in Europe. NDM disorders, which affect about 1 in 100,000 people in Spain, are rare inherited neuromuscular conditions that cause muscles to remain tense after voluntary contractions (myotonia). By reducing myotonia symptoms, NaMuscla® can significantly improve the quality of life and other functional and clinical outcomes for patients with NDM. Designated as an orphan drug, NaMuscla® received EU marketing authorization in December 2018.
“We are thrilled that NDM patients in Spain will now have access to NaMuscla®,” said Thierry Volle, President EMEA of Lupin. “We are grateful to all the stakeholders involved in the approval process, especially our partner Exeltis. Lupin is committed to investing in specialty disease areas, including neuromuscular diseases, in order to meet the unmet needs of patients.”
“This is great news for patients with NDM in Spain,” said Alberto Fábregas Gil, Director General of Spain and Portugal for Exeltis. “We are excited to be able to provide a new, innovative treatment option that addresses the unmet needs of these patients as soon as possible. The approval of NaMuscla® allows us to quickly and effectively distribute the drug and strengthen our presence in the central nervous system area.”
People living with NDM in Spain have previously had limited access to licensed treatment for myotonia, which can reduce the daily burden of this lifelong condition. This lack of access can lead to inconsistent medication supply, administrative challenges, and financial burdens for patients. It can also result in limited clinical experience among healthcare professionals due to the rarity of the disease, potentially causing significant harm to patients. This new reimbursement approval for NaMuscla® will help improve the situation for NDM patients in Spain.
Lupin is currently conducting a pediatric trial (NCT04624750) for NaMuscla® as part of a pediatric investigation plan for children with myotonic disorders. The trial successfully enrolled patients in a first cohort group and these patients have been rolled over into a 2-year follow-up study (NCT04622553). Additionally, a post-authorization study (NCT04616807) that aims to assess the long-term safety and treatment effects of NaMuscla® on patient-reported outcomes in adults with NDM has concluded patient enrollment and will provide 3 years of prospective data on the use of NaMuscla® in a real-life setting.
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