Santhera Pharmaceuticals (SIX: SANN)  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an extension to the marketing authorization for AGAMREE® (vamorolone) to include the treatment of patients with Duchenne muscular dystrophy (DMD) from 2 years of age.

AGAMREE is currently approved in the European Union for the treatment of DMD in patients 4 years of age and older. If confirmed by the European Commission, the CHMP opinion would expand the authorized age range to include children from 2 years of age, a population in which early anti-inflammatory intervention may offer long-term benefit, and where the tolerability burden of conventional corticosteroids remains a key concern.

Dario Eklund, Chief Executive Officer of Santhera, said: “This positive CHMP opinion marks an important step towards our goal of making AGAMREE available to every DMD patient who could benefit. For families and clinicians, deciding when to initiate treatment in very young children can be particularly challenging, given the limited treatment options available.”

Shabir Hasham, MD, Chief Medical Officer of Santhera, said: “Initiating anti-inflammatory therapy early in DMD has the potential to reshape the long-term trajectory of the disease. The CHMP’s positive opinion reflects the strength of the AGAMREE clinical and safety data and recognizes the need for better tolerated treatment options in young children. We remain committed to providing clinicians and families with a treatment option for this vulnerable population.”