J&J $JNJ played this one straight out to the end, but after an overwhelmingly negative expert panel vote against an approval of its troubled rheumatoid arthritis drug sirukumab, the FDA has formally rejected the marketing application — ominously demanding more data for review.
J&J said after the market closed Friday that it will study the situation on this drug, which some analysts once counted as a likely blockbuster-to-be.
Just ahead of the August 2 agency panel review, GlaxoSmithKline provided a preview of what was to come when it abruptly abandoned its 6-year partnership on this drug. Then the panel voted 12 to 1 against the therapy, after reviewing some troubling safety data.
At the time, it was another red flag for RA, following a similar rejection for Eli Lilly’s baricitinib. The FDA reversed its position on demanding a new study on Lilly’s drug after Scott Gottlieb took over as commissioner. But this time there was a clear indication that the FDA plans to follow through in keeping the light red on for sirukumab.
Several of the FDA’s experts shook their heads over what they agreed was troubling but somewhat mysterious evidence of an imbalance in deaths among the trial patients taking the drug. While J&J insisted that the overall evidence indicated that the risk/benefit ration justified an approval, some of the experts wondered why they would approve another IL drug with troubling safety signals while two other such drugs were already on the market that didn’t have the same safety problems.
“We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab in the treatment of moderately to severely active rheumatoid arthritis,” said Newman Yeilding, head of immunology development at Janssen. “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.”
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