FDA ‘Complete Response’ on Janssen Arthritis BLA

FDA has issued Janssen Biotech a complete response letter on a BLA for sirukumab and its use in treating moderately to severely active rheumatoid arthritis. The agency letter indicated that additional clinical data are needed to further evaluate the therapy’s safety, according to the company. Janssen plans to have a follow-up discussion with the agency to understand the requirements for approval.

The letter should not come as a surprise. On 8/2, FDA’s Arthritis Advisory Committee voted 12 to 1 against recommending approval, citing safety concerns raised in an FDA briefing document released in advance of the meeting. Its major findings were related to immunosuppression consistent with other disease-modifying anti-rheumatic drugs, but the reviewers also saw a trend of increased overall mortality with the therapy over placebo, according to the document. The common causes of mortality were major adverse cardiovascular events, infection and malignancy, it said.