Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy 

The Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for AGAMREE (vamorolone)’s approval in Europe. Vamorolone is a dissociative steroid for individuals with Duchenne that could offer an alternative to traditional corticosteroid treatments.  

In addition, the U.S. Food and Drug Administration (FDA) has set a target date for its decision on vamorolone for October 26, 2023, and if approved, it could be available in the U.S. as early as Q1-2024.  Although the CHMP’s opinion doesn’t have a direct bearing on the FDA’s evaluation of vamorolone’s new drug application, this favorable development brings hope to the Duchenne community in the United States. 

CureDuchenne is hopeful about the prospect of an additional treatment option for Duchenne, and we are proud to have provided early funding at a critical time in the drug’s development at ReveraGen BioPharma, along with other Duchenne groups.  

Read Santhera’s press release