Schering-Plough will have been cheered today on news that the European Commission has given its backing to the use of its billion-dollar biologic therapy Remicade (infliximab) in a new use – for the second-line treatment of patients with moderate to severely active ulcerative colitis.
UC is a chronic inflammatory bowel disease that affects more than 700,000 people in the European Union and can lead to ulceration of the innermost lining of the colon, bloody stools, severe diarrhoea and abdominal pain.
The approval means Remicade becomes the first biologic therapy to be given the thumbs up for UC in Europe, and also marks the eighth indication for the compound in the region. It was cleared by the US Food and Drug Administration for UC in September last year, and is available on both sides of the Atlantic for use in rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis and psoriatic arthritis. It is also approved in Europe to combat psoriasis.
This latest regulatory nod was based on data from the Active Ulcerative Colitis Trials, which showed the drug’s ability to heal the mucosal lining of the intestine. Of the 700-patient cohort, more than 60% of those given Remicade achieved mucosal healing after eight weeks' treatment, and 50% maintained this at 30 weeks’ follow-up. Importantly, Remicade therapy was also linked to clinical remission for many patients who had failed to respond to standard therapy with azathioprine and/or steroids, cutting hospitalisations in half versus the control arm.
Remicade may now be used in patients who have failed to respond to traditional therapy, including corticosteroids, 6-mercaptopurine or azathioprine. In UC, if conventional treatments do not control the symptoms of the disease, many patients face surgical removal of the colon - so this new label for Remicade could open the door to a very promising market indeed: in 2005, S-P reeled $942 million for the drug - which is partnered with Johnson & Johnson’s Centocor unit in the USA and Tanabe Seiyaku in Japan - into its own coffers, up 26% over the previous year.