FDA turns down Janssen's sirukumab for rheumatoid arthritis

The Arthritis Advisory Committee weighed in on the decision, reviewing efficacy and safety data derived from a Phase 3 trial programme encompassing more than 3,000 RA patients. The group found that the drug demonstrated "significant efficacy" in the treatment of the disease, minimsing progression and structural damage, reducing symptoms, and improving patient-reported outcome measures of quality of life.

Ultimately however, the FDA panel voted 12-1 against approving the drug, primarily citing concerns over safety; in particular, the imbalance in patient deaths versus the placebo group, primarily due to heart problems, infection and malignancies.  

Sirukumab is an anti-interleukin (IL)-6 monoclonal antibody which offers a different mode of action than the two other IL-6 inhibitors on the market: Roche’s Actemra and Sanofi and Regeneron’s Kevzara.

"We appreciate the advisory committee's thoughtful review and discussion of the sirukumab efficacy and safety data during today's meeting," said Newman Yeilding, Head of Immunology Development at Janssen. "While the committee voted unanimously in support of the efficacy data, there was uncertainty regarding the safety profile. As a result, the committee did not support approval for the proposed indication. We are disappointed and disagree with the group's interpretation of the sirukumab benefit-to-risk profile. We remain confident in the data accumulated to date supporting sirukumab in the treatment of moderately to severely active rheumatoid arthritis. We look to continue discussions with the FDA in their review of the application, as we believe sirukumab represents an important therapeutic option for patients with rheumatoid arthritis."