On 27 March 2026, the Danish Medicines Council (Medicinrådet) stated it cannot recommend vamorolone (Agamree) for Duchenne muscular dystrophy in patients from age 4.
The council cited two main reasons:
- Uncertain added benefit: Available studies include few patients and only children up to age 7, leaving no data for older children, adolescents, or adults, and no long-term data on effect, safety, or disease course.
- Markedly higher price: The treatment is priced significantly above current standard care.
Current standard treatment in Denmark is prednisolone or deflazacort, which is associated with long-term adverse effects, including impacts on growth. The council noted it is uncertain whether vamorolone has the same effect on the disease; studies suggest the effect may be worse, and it is also uncertain whether it offers fewer side effects.
The council encouraged the company to return with more solid data on effect and adverse events and a significantly lower price for reassessment. Around 160 patients in Denmark live with Duchenne muscular dystrophy.
