Sirukumab Turned Down by FDA Save

On Friday the U.S. Food and Drug Administration announced that will not approve Johnson & Johnson’s rheumatoid arthritis drug sirukumab, stating further data and study would be needed to establish its safety. 

In August, the Arthritis Advisory committee reviewed the company's application and unanimously voted down the approval of sirukumab (13-0), siting concerns about the imbalance in deaths seen for those treated with sirukumab, but not seen with placebo. The most common causes of death were major heart problems, infection and malignancies.

Data showed there were more SAE (serious adverse events) with sirukumab compared to placebo.  As seen with other IL-6 agents, SIR patients demonstrated increased numbers of patients with neutropenia, thrombocytopenia, hyperlipidemia and increased hepatic enzymes (in 44-58%). There were more cases of H.zoster on SIR vs PBO and a few cases of TB and GI perforations on SIR.

The FDA acted upon the recommendation of this subcommittee that noted that while the safety concerns and deaths were difficult to explain, they could not vote in favor of a 3rd IL-6 inhibitor, knowing these safety issues and that two other FDA approved IL-6 inhibitors ( tocilizumab and sarilumab) are commercially available.