Centocor, Schering Plough: Remicade approved in Europe for ulcerative colitis

By E. Janene Geiss

Philadelphia, March 9 - Centocor, Inc. and Schering-Plough Corp. announced Thursday that the European Commission has granted approval of Remicade (infliximab) for the treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies.

The approval makes Remicade the first biologic therapy approved to treat moderately to severely active ulcerative colitis in the European Union, addressing an unmet medical need for patients who previously had limited treatment options, according to a company news release.

This new approval also marks the eighth indication Remicade has received in the European Union for the treatment of immune-mediated inflammatory disorders.

The approval of Remicade for ulcerative colitis is based on data from two clinical trials. The trials were multi-center, phase 3, randomized, double-blind, placebo-controlled clinical trials conducted to evaluate the safety and efficacy of Remicade for the treatment of adult patients with moderately to severely active ulcerative colitis who experienced an inadequate response to conventional therapy.

"Our research demonstrated that ulcerative colitis patients treated with Remicade achieved mucosal healing and disease remission while they had failed conventional therapies," said Paul Rutgeerts of University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium, and the lead investigator of one of the trials, in the release.

This approval follows a positive opinion adopted on Jan. 26 by the European Union's Committee for Medicinal Products for Human Use for the European Agency for the Evaluation of Medicines.

The commission approval will now allow marketing authorization with unified labeling in all E.U.-member states, including the current 25 member states as well as Iceland and Norway, officials said.

Ulcerative colitis is a chronic inflammatory bowel disease affecting more than 700,000 people in the European Union. It is marked by the inflammation and ulceration of the colon mucosa, or innermost lining, which causes bloody stools, severe diarrhea and frequent abdominal pain.

Remicade is a monoclonal antibody that specifically targets TNF-alpha, which has been shown to play a role in Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and ulcerative colitis.

Centocor discovered Remicade and has exclusive marketing rights to the product in the United States.

Schering-Plough markets Remicade in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product and in China where Xian-Janssen markets Remicade.

Centocor, a wholly owned subsidiary of Johnson & Johnson, is a Horsham, Pa., research and biomanufacturing company that has developed treatments for Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and ulcerative colitis.

Schering-Plough is a Kenilworth, N.J., science-based health care company with leading prescription, consumer and animal health products.

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