Rockville, MD, USA, December 22, 2023
The EMA approved AGAMREE (vamorolone) for Duchenne muscular dystrophy (DMD), ages 4 years and older on 18 December 2023. The US FDA previously approved AGAMREE for DMD (26 October 2023). This makes AGAMREE the first pharmacological intervention poised to receive full approval for DMD populations in both the US and EU.
Pratteln, Switzerland, and Rockville, MD, USA, April 25, 2023
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the U.S. Food and Drug Administration (FDA) of the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
Pratteln, Switzerland, March 2, 2023
Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
Pratteln, Switzerland, October 31, 2022
Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Validation confirms that the submission is complete and that the review by the EMA’s Committee for Medicinal Products for Human Use (CHMP) has begun.
Pratteln, Switzerland, and Rockville, MD, USA, October 10, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of data relating to long-term efficacy, tolerability and the impact of vamorolone on bone health in patients with Duchenne muscular dystrophy (DMD) over 2.5 years of treatment [1].
Pratteln, Switzerland, October 3, 2022
Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
Pratteln, Switzerland, and Rockville, MD, USA, September 1, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen (US: Private) announce that JAMA Neurology has published positive results of the 24-week primary efficacy and safety analysis from the VISION-DMD study evaluating vamorolone, an investigational drug for the treatment Duchenne muscular dystrophy (DMD). Vamorolone met its primary endpoint by demonstrating statistically significant and clinically relevant improvement in time to stand from floor compared to placebo, the first functional milestone to deteriorate in young children with DMD.
Pratteln, Switzerland, and Rockville, MD, USA, August 22, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the first patient has been dosed in a Phase 2 pilot study to assess vamorolone in Becker muscular dystrophy (BMD), funded by the U.S. Food and Drug Administration (FDA).
Pratteln, Switzerland, and Rockville, MD, USA, June 9, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of new data with vamorolone in Duchenne muscular dystrophy (DMD).
Pratteln, Switzerland, March 29, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) announce the initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Vamorolone for DMD has been granted Fast Track Designation by the FDA.