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news.Janssen Biotech has received a complete response letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA).
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The complete response letter indicates additional clinical data are needed to further evaluate the safety of sirukumab in the treatment of moderately to severely active RA.
"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, M.D., Head of Immunology Development, Janssen Research & Development, LLC.
"We believe sirukumab represents an important therapeutic option for patients living with rheumatoid arthritis, especially for those individuals who cycle through multiple treatments and continue to struggle to find an effective option for a potentially disabling disease. 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 U.S. approval."
On August 2, 2017, the FDA's Arthritis Advisory Committee did not recommend approval of sirukumab for RA. Convened upon the request of the FDA, the committee reviews and evaluates safety and efficacy data of human products for use in the treatment of arthritis.
The committee provides non-binding recommendations based on its evaluation; however, the FDA makes the final decision on approval of the drug.
The sirukumab BLA, filed on September 23, 2016, included data from a global Phase 3 clinical development program inclusive of five studies and approximately 3,100 RA patients, including those who continued to have active disease despite previous use of disease-modifying anti-rheumatic drugs (DMARDs) and biologic treatments.
Sirukumab is a fully human monoclonal IgG1 kappa antibody that selectively blocks circulating interleukin (IL)-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 rheumatoid arthritis or for any other indication anywhere in the world.