Ulcerative Colitis

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

The approval of REMICADE for UC is based on data from the ACT 1 and ACT 2 (Active ACT 1 and ACT 2 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 UC who experienced an inadequate response to conventional therapy.

"Our research demonstrated that UC patients treated with REMICADE achieved mucosal healing and disease remission while they had failed conventional therapies," said Paul Rutgeerts, MD, PhD, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium and lead investigator of the ACT 2 clinical trial.

"These patients with UC had limited treatment options, with many facing surgery.

REMICADE represents a significant advance for these patients." This approval follows a posi...

The companies said Remicade is the first biologically derived drug approved in Europe for this particular indication.

The drug is approved for other inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.

A European advisory panel recommended the drug in January based on clinical trial data showing that 69 percent of email this print thisreprint or license this News Copyright ...

Centocor Inc., a wholly owned subsidiary of Johnson & Johnson, discovered REMICADE and has exclusive marketing rights to the product in the US.

Meanwhile, Schering-Plough markets REMICADE in all countries outside the US, except in Japan and China.

REMICADE, a monoclonal antibody that specifically targets TNF-alpha, plays a role in Crohn's disease/CD, rheumatoid arthritis/RA, ankylosing spondylitis/AS, psoriatic arthritis/PsA, psoriasis and The company noted that REMICADE is the only anti-TNF biologic therapy available as an IV form.

With the approval, REMICADE became the first biologic therapy to treat moderately to severely active UC in the EU, the company noted.

The approval also marks the eighth indication REMICADE has received in the EU for the treatment of immune-mediated inflammatory disorders.

The approval of REMICADE for UC was based on data from the Active The multi-center, Phase 3, randomized, double-blind, placebo-controlled, clinical trials were conducted to evaluate the safety and efficacy of REMICADE for the treatment of adult patients with moderately to severely active UC, with an inadequate response to conventional therapy.

The company noted that REMICADE is now approved in...