FDA rejects Johnson & Johnson’s rheumatoid arthritis drug sirukumab on safety grounds, demands more data

CEO at shareholders meeting
J&J CEO Alex Gorsky

The FDA has delivered its expected rejection of Johnson & Johnson’s rheumatoid arthritis drug sirukumab. J&J is now assessing what it will take to quell the agency’s concerns about the safety of the IL-6 monoclonal antibody before deciding on a path forward.

Those deliberations and the complete response letter that triggered them stem from the startling difference between the death rates in the sirukumab and control arms during development. Of the 35 trial participants who died within 16 weeks of the last dose, 34 were in the sirukumab arm. J&J argued the overall risk-benefit profile was favorable, but a series of other people and organizations have rejected that view.

RELATED: FDA panel snubs Johnson & Johnson’s rheumatoid arthritis drug sirukumab, citing worries about trial deaths


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GlaxoSmithKline dealt the first blow to sirukumab when it severed its ties to the drug just before the FDA advisory committee hearing. The committee then delivered the more telling punch when it voted 12 to 1 against approving the drug. And the FDA has now finished off the combination by going along with the advisory committee and formally rejecting the application.

J&J said the FDA’s rejection “indicates additional clinical data are needed to further evaluate the safety of sirukumab.” The Big Pharma plans to talk to the agency to discuss exactly what the FDA will need to approve the drug before deciding whether to double down or call it quits.

The calculation is complicated by uncertainty about how big a drug sirukumab could be for J&J. Management at the Big Pharma tipped the antibody to rack up blockbuster sales when setting out their growth plan earlier this year. But the FDA rejection means sirukumab is trailing well behind rival IL-6 drugs from Roche and the Regeneron-Sanofi collaboration. Those drugs are free from the safety concerns that dog sirukumab. 

The availability of other, apparently safer IL-6 drugs meant J&J faced an uphill struggle to win over the advisory committee and slim odds of the FDA ignoring the 12-to-1 rejection, although the agency’s reversal on baricitinib offered a glimmer of hope. 

The FDA rejected the Eli Lilly rheumatoid arthritis drug, only to perform a U-turn and drop its demand for additional data. That flip-flop added to evidence drugmakers may have an easier time at Scott Gottlieb’s FDA. But the agency’s decision to hold the line against sirukumab shows the door remains shut to some filings.    

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