Santhera has applied for marketing authorisation to the European Medical Agency for the drug vamorolone. The company is also pursuing an approval from the UK agency, the Medicines Healthcare Regulatory Agency (MHRA).
In 2015, Joining Jack, Duchenne UK and the The Duchenne Research Fund invested £750,000 to help develop phase one of this study towards a phase 1 clinical trial in boys with Duchenne Muscular Dystrophy, which then enabled Reveragen, the company developing vamorolone at the time, to win a £6million grant from Europe's Horizon 20/20 grant.
Subsequently, our funding of the DMD Hub has enabled swift recruitment to a pivotal vamorolone phase 2 trial in the UK. And and Santhera has been engaging with us and Project Hercules, our ground-breaking global collaboration to help companies overcome regulatory challenges, to ensure vamorolone’s approval and patient access in the UK.
The funding and development of this drug has been a community supported endeavour. Our thanks as always to the boys and families who took part in this study.
Read the full story here: https://www.santhera.com/health-care-professionals/vamorolone?fbclid=IwAR3-NNc-klx-y0TuOGy71Cj1u3HtI-em_JxqY9MPEdsXdNLI0tRM5ScxU_w