FDA Advisory Committee Does Not Recommend Approval Of Sirukumab For The Treatment Of Moderately To Severely Active Rheumatoid Arthritis

Markets Insider—August 2, 2017

Markets Insider featured HSS rheumatologist Sergio Schwartzman, MD in a press release about the FDA Advisory Committee’s recent decision to not recommend approval of sirukumab, a drug created to treat rheumatoid arthritis. Sirukumab was designed as an alternative treatment for adults with rheumatoid arthritis who were intolerant to one or more disease modifying anti-rheumatic drugs.

The decision is due to uncertainty regarding the drug’s safety profile. Dr. Schwartzman commented on the decision and said, "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. 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," he added.

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