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 for treatment of adults and adolescents (16-17 years) with Crohn’s Disease (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.
The acceptance of risankizumab on the EAMS underscores the debilitating nature and high unmet need associated with CD, the company said.
CD is a chronic, progressive condition of the digestive system, associated with inflammation and mucosal ulceration. The pain, physical symptoms and complications of CD lead to low quality of life, have a significant impact on people’s daily activities and work, and mental health consequences 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.
“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”, said Dr Mark Samaan, Consultant Gastroenterologist, Guy’s and St Thomas’ NHS Foundation Trust. “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.”
“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, AbbVie UK. “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.”