Schering-Plough receives EU Remicade approval for Crohn’s disease

The European Commission has approved a label change for Remicade that will allow the drug to be administered in the treatment of Crohn’s disease for patients who do not respond to corticosteroid or immunosuppressant treatment, according to Schering-Plough.

Remicade, which was discovered by Centocor, the Johnson & Johnson subsidiary, is and anti-TNF therapy marketed by Schering-Plough in the EU, can now be used as a second-line treatment in EU member states, whereas before the drug was indicated for third-line treatment.

The approval of the drug follows the submission of positive clinical trials. In one trial, 39 per cent of subjects receiving the 5mg/kg dosage of Remicade achieved clinical remission 30 weeks into the trial, compared to 25 per cent of the placebo group. Additionally, Remicade patients demonstrated a longer time to “loss of response” than those receiving the placebo.

Robert Spiegel, chief medical officer and senior vice president of the Schering-Plough Research Insititute, remarked: “The approval of Remicade as a second-line therapy offers a new option to patients suffering from active Crohn’s disease for which other therapies do not provide relief.”

Remicade is also used in the treatment of rheumatoid arthritis, ulcerative colitis and ankylosing spondylitis.

The drug was also approved by NICE to treat psoriatic arthritis in July along with Enbrel, the Wyeth drug.