The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for AbbVie’s risankizumab as a treatment for Crohn’s disease (CD).
The decision means that the following people will now gain access to risankizumab while review of the UK marketing authorisation application continues:1
- Adults with CD who have had an inadequate response to, lost response to or were intolerant or contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies, vedolizumab and ustekinumab.
- Adolescents aged 16-17 years with CD who have had an inadequate response to, lost response to or were intolerant or contraindicated to TNFα antagonist therapies.
Dr Mark Samaan, Consultant Gastroenterologist, Guy’s and St Thomas’ NHS Foundation Trust said: “On top of the daily impact of living with moderate to severe Crohn’s disease, people who have exhausted current treatment options face ongoing worry for their future, due to the progressive damage caused by the disease. There is an ongoing unmet need for new treatment options that target different parts of the inflammatory pathway, and access to risankizumab through the EAMS is an immensely positive step forward in the care of people with Crohn’s disease.”
Belinda Byrne, Medical Director, AbbVie UK said: “We are committed to addressing the significant burden that Crohn’s disease continues to have on the lives of people with the condition. Working with the MHRA to bring risankizumab to eligible people with Crohn’s disease reflects our ambition to bring innovative medicines to people with debilitating conditions like inflammatory bowel disease as quickly as possible.”