Ulcerative Colitis

"The CHMP's positive opinion represents a milestone in the treatment of Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.

"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." The CHMP recommendation is an important step towards a European Commission approval.

A Commission approval of the application will result in Marketing Authorization with unified labeling that will be valid in all EU-member states, including the current 25 member states as well as Iceland and Norway.

The positive opinion for REMICADE for UC is based on data from the ACT 1 and ACT 2 clinical trials.

ACT 1 and ACT 2 were multicenter, Phase 3, randomized, double-blind, placebo-controlled, clinical trials conducted to evaluate t...

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