EU Regulators Recommend Golimumab for Ulcerative Colitis


July 26, 2013

European Union (EU) drug regulators have announced that they have recommended approval of golimumab (Simponi, Janssen Biologics) for moderate to severe ulcerative colitis in adults who fail to respond to conventional therapies or who should not receive them.

Conventional therapies for ulcerative colitis include corticosteroids and 6-mercaptopurine or azathioprine.

Golimumab, a monoclonal antibody, inhibits tumor necrosis factor alpha, a culprit in inflammatory diseases.

The recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) follows in the footsteps of the May 15 decision by the US Food and Drug Administration to approve golimumab for ulcerative colitis. The drug is indicated in the United States as well as the EU for 3 other conditions: moderate to severe rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis, and ankylosing spondylitis.

The European Commission, the executive branch of the EU, is expected to approve the EMA recommendation in the next several months.

More information on the EMA recommendation is available at the agency's Web site.


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