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Setback for J&J as FDA panel turns down arthritis drug sirukumab

US regulator concerned with the drug’s safety


An FDA advisory committee delivered a blow to Johnson & Johnson (J&J) yesterday, voting 12 to 1 against approving its IL-6-targeting arthritis candidate sirukumab.

The panellists were unanimously of the opinion that the data provided by J&J on sirukumab's efficacy passed muster, but said data on safety wasn't convincing enough.

The rejection comes after J&J's partner GlaxoSmithKline announced last week that it would drop sirukumab from its pipeline as part of an R&D shake-up, and after FDA reviewers said they had concerns about the safety of the drug, particularly an imbalance of patient deaths in trials.

J&J is seeking approval of sirukumab as a treatment for adults with moderate to severe rheumatoid arthritis (RA) - who respond inadequately to or can't tolerate one or more disease-modifying anti-rheumatic drugs (DMARDs) like methotrexate. The drug was filed for approval in Europe last September and is still awaiting a verdict from the CHMP.

The FDA has already approved two other IL-6-inhibiting antibodies for RA, namely Roche's Actemra (tocilizumab) in 2010, which made sales of $1.7bn last year and Sanofi/Regeneron's Kevzara (sarilumab), which was approved in the US in May at the second attempt.

Unlike Actemra and Kevzara, which target the IL-6 receptor, J&J's drug targets the IL-6 molecule itself. Committee members questioned why they should vote in favour of approving a new IL-6 inhibitor with safety questions when there are two alternative options already in the marketplace.

Sarilumab also outperformed AbbVie's market-leading, $13bn-a-year TNF blocker Humira (adalimumab) in head-to-head trials, while sirukumab achieved mixed results, besting its rival on one measure but failing to meet that objective across all patient groups.

"While the committee voted unanimously in support of the efficacy data, there was uncertainty regarding the safety profile," said Newman Yeilding, head of immunology at J&J's Janssen Biotech unit. "We are disappointed and disagree with the group's interpretation of the sirukumab benefit-to-risk profile."

J&J chief executive Alex Gorsky said recently he believes there will be a role for sirukumab in the treatment spectrum because there is a lot of variability between patients in their response to IL-6 inhibitors.

Article by
Gemma Jones

3rd August 2017

From: Regulatory



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