Santhera has announced that the MHRA (the UK’s drug and medicines regulator) has granted a renewal of the Early Access to Medicines Scheme scientific opinion for Raxone. The renewal will last 12 months from 21 June 2018 and means that clinicians can continue to offer Raxone to their patients.
The drug can slow the decline of respiratory function for those living with Duchenne muscular dystrophy who are at least 10 years old and who are currently not taking steroids. As part of the renewal process, Santhera has slightly altered the detailed eligibility requirements for those who can be offered the drug.
During the EAMS, the drug must be provided free of charge by Santhera and this will continue until funding decisions are made by the NHS after a marketing authorisation is granted. Santhera is currently preparing an application for a marketing authorisation for using Raxone in DMD – a process expected to take around 2 years.
Find out more
- Contact Neil Bennett, Director of Research, to find out more on 020 7250 8240
- Book ‘early bird’ 2 for 1 tickets for the Action Duchenne Conference
- More about potential therapies for Duchenne
Sarepta announce early, preliminary gene therapy trial results
