Takeda UK, a subsidiary of Japan’s leading pharmaceutical company, recently achieved a pioneering milestone when the National Institute for Health and Care Excellence (NICE) granted Entyvio® (vedolizumab) a positive provisional recommendation in the form of an Appraisal Consultation Document (ACD), as a maintenance therapy for adult patients with moderate to severe ulcerative colitis who have not undergone or cannot tolerate treatment with TNF-alpha inhibitors. The recommendation comes 6 months after the drug’s licensure in the UK. In 2008, Infliximab for acute, severe UC had also received NICE approval, but only as an induction treatment with 3 infusions.
Vedolizumab is a groundbreaking biologic that specifically works on the intestine, thereby reducing systemic side effects. NICE recognized the drug’s ability to suppress hyperactive immune responses only in the gut, and believed it to be a pivotal option in the long-term management of UC.
“We are delighted with today’s landmark provisional decision, as it means many patients could have access to an effective new treatment for this lifelong condition,” said Hiro Fukutomi, Managing Director, Takeda UK. “We will continue to work with NICE to ensure that vedolizumab is a treatment option for all appropriate patients.”
More than 140,000 UK residents suffer from ulcerative colitis, a type of inflammatory bowel disease that causes a number of uncomfortable symptoms that can greatly reduce one’s quality of life, such as diarrhea, rectal bleeding, and extreme fatigue. It is estimated that at least half of UC patients will experience a relapse of the disease at least once a year, with 20% requiring hospitalization. Unfortunately, UC still has no known cure and requires life-long treatment, and 20-30% of patients will be forced to undergo complex surgery to remove their chronically inflamed large intestine.
UC experts presented these facts to NICE, including supporting data on the long-term and life-altering effects of surgery. The irreversible procedure can affect fertility, poses serious risks, and can greatly limit a patient’s lifestyle and intimacy with partners. Additionally, UC patients who do not experience remission, or improvement from standard treatments are clamoring for better options. Entyvio may be the alternative solution these patients have been waiting for as this drug has performed impressively in clinical trials, inducing remission in over 40% of patients at the end of 1 year of treatment, and mucosal healing in more than half.