Spain approves Duchenne treatment AGAMREE for national healthcare coverage
Santhera Pharmaceuticals is rolling out its Duchenne muscular dystrophy treatment, AGAMREE, across Europe. The drug, already approved in several major markets, is now set for wider availability in Spain by early 2026. Patients will soon benefit from a new alternative to traditional steroid therapies.
AGAMREE (vamorolone) has been available to a limited number of Spanish patients since mid-2024 through an early-access scheme. Now, the country's interministerial drug pricing commission has recommended its inclusion in the national health system's reimbursement programme. Once final approval comes from Spain's General Directorate of Pharmacy, the treatment will be fully covered for patients aged four and older.
The drug's expansion follows successful clinical results. In the VISION-DMD trial, AGAMREE met its primary goal, showing a significant improvement in the speed at which patients could rise from the floor after 24 weeks compared to a placebo. Unlike conventional corticosteroids, it works through a novel mechanism, offering a different approach for managing the disease.
Beyond Spain, Santhera plans to launch AGAMREE in several additional EU countries throughout 2026, building on its existing approvals in the U.S., UK, China, and Hong Kong. The company has also secured out-licensing deals with Catalyst Pharmaceuticals, Sperogenix Therapeutics, and Nxera Pharma to support global distribution.
With Spain's public healthcare system now covering AGAMREE, more patients will access the treatment without direct costs. The drug's listing in Spain's state-funded treatment database will follow final approval. Wider availability across Europe is expected to progress steadily over the next two years.
