Santhera Pharmaceuticals announces that the Spanish Interministerial Commission on Prices of Medicines, has proposed to include AGAMREE (vamorolone), in the pharmaceutical coverage of the Spanish National Health System, making it eligible for reimbursement. Learn More: What is AGAMREE (Vamorolone)
The conditions for such inclusion will be determined in a resolution by the Directorate-General of Pharmacy at the Spanish Ministry of Health. The company expects to receive the draft of such resolution shortly. Once the company accepts the draft, the product will be included in the database of products financed by the National Health System in Spain. Assuming this process proceeds along typical timelines, Santhera plans to start to make the product available across the various regions in Spain from early in the second quarter of 2026.
Agamree is a product approved by the European Commission for treating Duchenne muscular dystrophy in patients from 4 years of age. Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function. To date, AGAMREE has been available in Spain through a paid named-patient program since mid-2024.
Dario Eklund, Chief Executive Officer of Santhera, said: “This positive announcement in Spain represents another important milestone in our mission to expand access to AGAMREE for patients with DMD in Europe and globally. This follows our commercial launches in Germany, Austria and the UK with a number of additional EU countries expected to follow during both the first and second halves of the year.”
Read More: Clinical Trials for Duchenne (List of All Researches)
