J&J Gets Complete Response Letter for RA Biologic

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FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

Janssen Biotech, a Johnson & Johnson (J&J) company, announced on Sep. 22, 2017 that it received a complete response letter from FDA for it biologics license application (BLA) seeking approval of sirukumab for treating moderately to severely active rheumatoid arthritis (RA). The complete response letter indicates additional clinical data are needed to further evaluate the safety of the biologic in this indication.

“We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab in the treatment of moderately to severely active rheumatoid arthritis,” said Newman Yeilding, MD, head of Immunology Development, Janssen Research & Development, in a company press release. “…We are reviewing the details of the complete response letter and plan to have a follow-up discussion with the agency to gain a full understanding of FDA requirements for US approval.”

The letter follows an Aug. 2, 2017 event where FDA’s Arthritis Advisory Committee did not recommend approval of sirukumab for RA. The BLA, filed on Sep. 23, 2016, included data from a global Phase III clinical development program inclusive of five studies and approximately 3100 RA patients, including those who continued to have active disease despite previous use of disease-modifying anti-rheumatic drugs and biologic treatments.

Sirukumab is a fully human monoclonal immunoglobulin G1 kappa antibody that selectively blocks circulating interleukin-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA. It is not yet approved as a treatment for RA or for any other indication anywhere in the world. The biologic is currently under review by health authorities in Europe and Japan as a subcutaneous therapy for treating moderately to severely active RA.


Janssen holds exclusive rights to commercialize sirukumab in Europe, the Middle East, Africa, and Asia Pacific and will regain exclusive, worldwide commercial rights in November 2017 from GlaxoSmithKline.

Source: Johnson & Johnson