CHMP adopts positive opinion on Simponi for axial spondyloarthritis

The Committee for Medicinal Products for Human Use has adopted a positive opinion recommending a change to marketing terms that would allow Simponi to be marketed for the treatment of non-radiographic axial spondyloarthritis, according to a press release from the European Medicines Agency.

Simponi (golimumab, Janssen) is now indicated for the treatment of severe, active, non-radiographic axial spondyloarthritis in adults who have had inadequate response to other treatments, such as NSAIDs, and present with objective signs of inflammation, including elevated C-reacted protein (CRP) levels or evidence of inflammation visible on MRI. Upon issuance of the European Commission’s decision, if approved, golimumab will be able to be used as an add-on therapy to methotrexate in a monthly, subcutaneous injection for patients with non-radiographic axial spondyloarthritis (nr-axial SpA).

In Europe, Russia and Turkey, golimumab is licensed by Janssen to a subsidiary of Merck for marketing, according to the press release.

“The indication of Simponi in nr-axial SpA will add to a number of existing indications in rheumatology and gastroenterology,” Sean Curtis, MD, vice president of immunology clinical research at Merck, said in the release. “Physicians will have an option to help address the treatment needs of a significant group of their patients.”

Currently, golimumab is approved in Europe and the U.S. for treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. Its use in axial spondyloarthritis had been approved in the U.S. previously. The positive opinion issued must be approved by the European Commission and described in an updated summary of product characteristics before taking effect.

Referenc e: www.ema.europa.eu.