FDA Advisory Panel Votes Against Approval Of Johnson & Johnson’s Sirukumab

August 3, 2017
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – The future of Janssen’s rheumatoid arthritis drug sirukumab is in question following a resounding rejection from a U.S. Food and Drug Administration advisory panel.

The arthritis advisory committee voted 12-1 against the approval of sirukumab, Janssen, a subsidiary of Johnson & Johnson , announced this morning. That rejection came days after a 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.

“The common causes of mortality were MACE, infection, and malignancy. The increased mortality was seen with both sirukumab doses at comparable rates. 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.

The arthritis committee seemed to agree with the review. Beth Jonas, interim head of the division of rheumatology at the University of North Carolina School of Medicine and a panel member said the safety “is not there” concerning sirukumab, Reuters reported this morning. Maria Suarez-Almazor, rheumatology section chief at the University of Texas MD Anderson Cancer Center, said she would be more enthusiastic about sirukumab if it was a new agent, Reuters said.

“There is no reason to think that this new drug will act in a tremendously different way,” Suarez-Almazor said in a statement.

Another concern raised by panelists Reuters noted was that 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.

The FDA is not required to follow the recommendations of the advisory panel, but typically does.

Newman Yeilding, head of immunology at Janssen, said the company was disappointed with the panel’s vote and disagreed with “the group's interpretation of the sirukumab benefit-to-risk profile.”

"We remain confident in the data accumulated to date supporting sirukumab in the treatment of moderately to severely active rheumatoid arthritis. We look to continue discussions with the FDA in their review of the application, as we believe sirukumab represents an important therapeutic option for patients with rheumatoid arthritis,” Yeilding said in a statement that echoed one sent to BioSpace earlier this week.

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.