FDA advisory committee does not recommend approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis.
Janssen Biotech, Inc. announced Wednesday afternoon that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) did not recommend approval of sirukumab (proposed trade name Plivensia) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
Sirukumab is an anti-interleukin (IL)-6 monoclonal antibody that blocks the IL-6 pathway differently than IL-6 inhibitors currently approved for the treatment of RA. Janssen Biotech, Inc. announced submission of a Biologics License Application (BLA) to the FDA seeking approval of sirukumab on September 23, 2016.
“We appreciate the advisory committee’s thoughtful review and discussion of the sirukumab efficacy and safety data during today’s meeting. 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,” said Newman Yeilding, M.D., head of immunology development, Janssen Research & Development, LLC. “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.”
The Arthritis Advisory Committee is convened upon the request of the FDA to review and evaluate safety and efficacy data of human products for use in the treatment of arthritis. While the FDA is not bound by the committee’s recommendation, it does take its advice into consideration.
The committee reviewed sirukumab efficacy and safety data from a global Phase 3 clinical development program inclusive of five studies and more than 3,000 patients living with RA, including those who continue to have active disease despite previous DMARD and biologic treatments. Sirukumab, studied at 50 mg and 100 mg doses every four and two weeks, respectively, demonstrated significant efficacy in the treatment of RA, improving signs and symptoms, inhibiting the progression of structural damage and demonstrating improvement in patient-reported outcome measures including fatigue, pain, quality of life and physical function.
The most common adverse events (AEs) reported in the sirukumab clinical development program included laboratory abnormalities, colds, upper respiratory tract infections, and redness, pain or swelling at the injection site. Serious AEs reported included serious infections such as pneumonia and cellulitis, abscess, sepsis, osteomyelitis, hypersensitivity reactions, low platelets, lipid elevations and gastrointestinal perforations. Cardiovascular adverse events, malignancies and mortality were observed in sirukumab clinical studies.
“Rheumatoid arthritis continues to be a disease with a high unmet need for many patients who are intolerant to or lose response over time to currently available treatment options,” said Sergio Schwartzman, M.D., Weill Cornell Medical College, Hospital for Special Surgery, New York Presbyterian Hospital, an external consultant. “The availability of alternative treatment options, including a new molecular entity like sirukumab, is critically important in my ability as a practicing rheumatologist to help patients control their disease, especially considering the complexity and heterogeneity of an autoimmune disease like rheumatoid arthritis. It is my hope that the FDA carefully considers all of the Phase 3 data and the current need for additional rheumatoid arthritis treatment options on behalf of patients and practicing rheumatologists.”
(Source: PR Newswire)