We are delighted to hear that the Medicines and Healthcare products Regulatory Agency has granted marketing authorisation for Ipsen’s Bylvay® (odevixibat) for the treatment of cholestatic pruritus in Alagille syndrome in patients aged six months and older.
The drug will now need to go through the NICE (National Institute for Health and Care Excellence) appraisal process before it can be approved for use on the NHS for treatment of this distressing symptom of Alagilles.
“Alagille syndrome can have a devastating impact on those affected – for the infants and young children suffering with symptoms, as well as the parents and carers that can so often feel helpless,” said Michelle Wilkins, Head of Children and Families Service at the British Liver Trust. “This decision recognises the unmet need that exists within the Alagille community and the potential benefits a new treatment option can bring.”
More details on the MHRA decision and on Bylvay are here
