FDA Requests Additional Data on Sirukumab for Rheumatoid Arthritis

Officials with the FDA are requesting additional clinical data before further evaluating the safety of sirukumab (Janssen) in the treatment of moderately to severely active rheumatoid arthritis (RA), according to a prepared statement from the company.

Sirukumab is an anti-interleukin (IL)-6 monoclonal antibody designed to block the IL-6 pathway in a different way than currently approved IL-6 inhibitors, according to a press release.

A Biologics License Application (BLA) for sirukumab was submitted to the FDA on September 23, 2016, seeking approval to treat patients with RA who had an inadequate response or are intolerant to 1 or more disease-modifying anti-rheumatic drugs (DMARDs). Last month, however, the FDA’s Arthritis Advisory Committee did not recommend the approval of sirukumab.

“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,” Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC said in the statement. “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 US approval.”

The sirukumab BLA included data from a global phase 3 clinical development program inclusive of 5 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.