FDA Rejects Johnson & Johnson's RA Drug Sirukumab, More Safety Data Needed

Published: Sep 26, 2017

FDA Rejects Johnson & Johnson's RA Drug Sirukumab, More Safety Data Needed
September 25, 2017
By Alex Keown, BioSpace.com Breaking News Staff

HORSHAM, Penn. – The regulatory rejection for Janssen’s rheumatoid arthritis drug sirukumab is complete. On Friday, the U.S. Food and Drug Administration issued the company a Complete Response Letter calling for additional clinical data to evaluate the safety of the drug.

The FDA rejection was not unexpected. In August, an FDA advisory panel overwhelmingly rejected the rheumatoid arthritis drug in a 12 to 1 vote. The rejection followed the release of an FDA briefing document raised concerns over the safety of sirukumab. In that document posted at the end of July, the review said there was a clear imbalance in deaths and malignancies among the patients who took the drug over a 52-week period. The panel noted there have been more deaths associated with patients taking the drug than those taking placebo.

Newman Yielding, head of Janssen’s immunology development program, called the rejection disappointing. He said the company believes the data accumulated during the clinical trials “support the efficacy and safety of sirukumab” in treating patients with rheumatoid arthritis.

"We believe sirukumab represents an important therapeutic option for patients living with rheumatoid arthritis, especially for those individuals who cycle through multiple treatments and continue to struggle to find an effective option for a potentially disabling disease. We are reviewing the details of the complete response letter and plan to have a follow-up discussion with the agency to gain a full understanding of FDA requirements for U.S. approval,” Yielding said in a statement.

In its briefing document issued earlier this summer, the FDA said the deaths associated with sirukumab were typically related to major adverse cardiac events (MACE), infection, and malignancy. Sirukumab was associated with increased risk of serious infection, and there were reports of opportunistic infection and tuberculosis. Sirukumab treatment was associated with laboratory abnormalities including neutrophil count decrease, liver function test values increase, and increase in lipid parameters of LDL, HDL, and triglyceride,” the FDA said in its briefing document.

There are already two RA drugs on the market that are in the same class as sirukumab, including the recently approved Kevzara, which was co-developed by Sanofi and Regeneron. Sirukumab, which would be marketed as Plivenzia if approved, is a human anti-interleukin (IL)-6 monoclonal antibody in development for the treatment of adults with moderately to severely active rheumatoid arthritis.

Rheumatoid arthritis is a chronic inflammatory condition characterized by pain, swelling of the joints, stiffness and disability. There are approximately 1.5 million people in the United States who have been diagnosed with RA, according to Janssen.

Janssen is also seeking regulatory approval for sirukumab in Europe and Japan.

Janssen isn’t the only company to be stymied with bringing a new RA drug to market. In April, the FDA rejected RA drug baricitinib, which is being developed by Eli Lilly and partner Incyte Corporation. In July, the two companies announced there would be a significant delay in refiling for approval of the drug. The FDA raised concerns over blood clots.

Shares of Johnson & Johnson, Janssen’s parent company, are down slightly this morning, trading at $131.13 as of 9:59 a.m.

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