The agency has recommended Remicade for the treatment of moderate to severe ulcerative colitis in patients who have had little success with conventional therapies.
Ulcerative colitis is an inflammation of the large intestine that can lead to abdominal pain amongst other unpleasant symptoms. It is thought to affect around 700,000 people in Europe.
At the moment there are no biologic therapies approved in the European Union giving patients who are unsuitable for the current treatments limited alternative options.
“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,” said Dr Robert Spiegel, chief medical office at Schering-Plough Research Institute.