Santhera Submits Marketing Authorization Application to UK MHRA for Vamorolone in Duchenne

  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).

In parallel to the MAA submission to the UK MHRA, Santhera is currently preparing an application to include vamorolone for the treatment of DMD in the Early Access to Medicines Scheme (EAMS) in the UK. The aim of the EAMS is to provide patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization, when there is a clear unmet medical need.

https://www.biospace.com/article/releases/santhera-submits-marketing-authorization-application-to-the-uk-mhra-for-vamorolone-in-duchenne-muscular-dystrophy-/