ReveraGen BioPharma has received Promising Innovative Medicine (PIM) status from the UK medicines regulator for its Duchenne muscular dystrophy (DMD) candidate vamorolone.
The decision marks the first step towards entry into the Early Access to Medicines Scheme (EAMS), which aims to give people access to promising new drugs that are not yet licensed.
Vamorolone is a first-in-class drug candidate that binds to the same receptors as corticosteroids but modifies the downstream activity of the receptors.
It has been granted Orphan Drug status in the USA and in Europe, and has received Fast Track and Rare Pediatric Disease designations by the US FDA.
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