The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a positive opinion under the Early Access to Medicines Scheme (EAMS) for AbbVie’s risankizumab.
The MHRA specified that certain patient groups will be able to access the treatment for moderate to severe uncontrolled Crohn’s disease (CD), while a review of the UK marketing authorisation continues.
Patients who are now eligible for treatment with risankizumab include adults, and adolescents aged 16 to 17 years old, with CD who have not responded well to vedolizumab and ustekinumab, or for whom the drugs were contraindicated.
Having risankizumab available via the early access scheme is a positive step for patients living with the chronic, progressive condition that affects the digestive system. The scheme aims to provide early access to innovative drugs for UK patients ahead of marketing authorisation, where there is a critically unmet need for new medicines.
CD is typically associated with inflammation and mucosal ulceration. The pain, physical symptoms and complications of CD can have a significant impact on people’s daily activities, often leading to mental health issues including depression and anxiety.
It is estimated that there are over 217,000 people aged 16 and over living with the condition in the UK and 40% have moderate or severe CD.
Not only does CD negatively impact those living with the condition, it also results in a considerable burden on healthcare systems, with Hospital Episodes Statistics reporting there were over 122,000 hospital admissions related to CD.
“We are committed to addressing the significant burden that Crohn’s disease continues to have on the lives of people with the condition,” said Belinda Byrne, medical director at AbbVie UK.
She added: “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.”