EU approves label enhancement variations for Remicade

These approvals follow positive opinions granted in September and October, respectively, by the Committee for Medicinal Products for Human Use for the European Medicines Agency.

Based on analysis from clinical studies in Crohn’s disease (CD), the Remicade label information was updated to include the following: healing the lining of the bowel (mucosal healing), tapering the use of corticosteroids for both severe active CD and fistulizing CD, reducing disease-related hospitalizations for both severe active CD and fistulizing CD and surgeries for fistulizing CD and improving quality of life for both severe active CD and fistulizing CD.

The enhancement to the psoriatic arthritis (PsA) labeling includes the improvement of physical function and reduction of the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of PsA. The ankylosing spondylitis (AS) label indication has been broadened to include adults with severe active AS who have responded inadequately to conventional therapy. The label also includes a significant improvement in physical function and quality of life.

Robert Spiegel, chief medical officer and senior vice president, Schering-Plough Research Institute, said: “The additional validation that Remicade can result in mucosal healing is important to patients, and gastroenterologists who agree that this should be a short-term and long-term goal in treating Crohn’s disease. These latest label enhancements allow physicians to utilize in the treatment of active severe CD and fistulizing CD.”