October 18, 2017
1 min read

Janssen Biotech will not pursue global approval for sirukumab

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Janssen Biotech Inc. announced the company will not seek global approvals of sirukumab for the treatment of moderately to severely active rheumatoid arthritis.

“We have made the difficult decision to withdraw the applications we had filed globally for sirukumab in rheumatoid arthritis. We maintain our belief in the efficacy and safety of sirukumab, an anti-interleukin-6 monoclonal antibody. However, the need for additional clinical data would result in significant delays to patient access in parts of the world. Given this, as well as the availability of other treatments targeting the IL-6 pathway, Janssen has made a strategic decision to prioritize other assets in our portfolio,” Brian Kenney, global therapeutic area communication leader, Immunology, for Janssen Research & Development LLC, told Healio Rheumatology.

In September, the company received a complete response letter from the FDA for the biologics license application which sought approval of sirukumab for the treatment of moderately to severely active RA among patients who have had an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs. The letter requested additional clinical data to evaluate the safety of the treatment. This was preceded by an August FDA Arthritis Advisory Committee meeting where the committee voiced safety concerns and voted 1-12 against recommending approval of the biologics license application for sirukumab. The meeting focused on one phase 2 dose-ranging study and three phase 3 studies that assessed the efficacy and safety of sirukumab.

“We are disappointed that we were not able to meet the needs of RA patients with sirukumab, yet remain deeply committed to research and development of transformational medicines for people around the world. We are profoundly grateful to the patients and physicians who contributed to the sirukumab program, expanding the understanding of RA and providing important insights for future research,” Kenney said. – by Kristine Houck, MA, ELS