E.U. committee recommends approval of Remicade for active ulcerative colitis

By E. Janene Geiss

Philadelphia, Jan. 30 - Centocor, Inc. and Schering-Plough Corp. announced Monday that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending the approval of an expanded indication for Remicade (infliximab) to include treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Currently, there are no biologic therapies approved to treat moderately to severely active ulcerative colitis in the European Union, leaving patients with limited treatment options, according to a company news release.

"The CHMP's positive opinion represents a milestone in the treatment of ulcerative colitis where an unmet need in effective therapy currently exists," Robert J. Spiegel, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute, said in the release.

"In the pivotal clinical studies, patients receiving Remicade achieved high rates of clinical response and clinical remission as well as mucosal healing and reduced rates of hospitalization. These are excellent results for this patient population that had failed available therapeutic options," Spiegel added in the release.

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.

The CHMP recommendation is an important step toward a European Commission approval, officials said. A commission approval of the application will result in marketing authorization with unified labeling that will be valid in all E.U.-member states, including the current 25 member states as well as Iceland and Norway, officials said.

The decision for Remicade for ulcerative colitis is based on data from two clinical trials. The trials were multicenter, 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.

A total of 728 patients with active disease who were unresponsive to at least one standard therapy, including corticosteroids and other immunosuppressants or 5-ASAs, were enrolled in the trials.

In these studies, the primary assessments of efficacy were based on clinical response, defined as a decrease from baseline, accompanied by a decrease in rectal bleeding and clinical remission.

In the first trial, at week eight, 69% of patients in the Remicade 5 mg group and 62% of patients in the Remicade 10 mg group were in clinical response, compared with 37% of patients in the placebo group for both comparisons.

In the second trial, at week eight, 65% of patients in the 5 mg group and 69% of patients in the 10 mg group were in clinical response compared with 29% of patients in the placebo group.

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.

Based in Horsham, Pa., Centocor is a wholly owned subsidiary of Johnson & Johnson. The pharmaceutical company, which specializes in monoclonal antibody production and technology, 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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