Vamorolone is a “dissociative” synthetic steroid developed by Santhera and ReveraGen for Duchenne muscular dystrophy, as an anti-inflammatory treatment alternative to conventional corticosteroids.
- The FDA has granted marketing authorisation for Agamree® (vamorolone) in DMD patients from the age of 2 (drinkable suspension, 40 mg/ml). Four studies of vamorolone in DMD patients aged between 4 and 7 years were used in the FDA application, including one comparative study with prednisone.
- The results of these studies show that vamorolone has positive functional effects similar to those of the corticosteroids normally used.
- In Europe, the marketing authorisation application for Agamree® is currently being examined. The CHMP ruled in favour of marketing authorisation on October 13. A decision is expected by the end of 2023.
Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy. Santhera, Press release, 27 October 2023
Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy. Santhera, Press release, 13 October 2023
