Irukumab Dropped by Johnson & Johnson Following FDA Blow

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Early this year, Johnson & Johnson highlighted sirukumab and talactuzumab as part of a wave of upcoming blockbusters that would push growth for years to come. Today, J&J ditched plans to win approval of its once much anticipated arthritis drug sirukumab and it halted a phase 3 trial of talacotuzumab in acute myeloid leukemia. Following the FDA’s rejection of the anti-IL-6 monoclonal antibody, the likelihood of J&J abandoning sirukumab increased. After the rejection, J&J said it would look into what it would take to address the FDA’s concerns about the number of people who died after taking sirukumab in clinical trials.

The FDA is requesting additional clinical data and sirukumab already trailing other, seemingly safer, IL-6 drugs from Roche and the Regeneron-Sanofi alliance, J&J decided to cut its losses even though it maintained its belief in the antibody. A spokesperson for J&J stated, “We have made the difficult decision to withdraw the applications we had filed globally for sirukumab in rheumatoid arthritis, the need for additional clinical data would result in significant delays to patient access in parts of the world. Given this, as well as the availability of other treatments targeting the IL-6 pathway, Janssen has made a strategic decision to prioritize other assets in our portfolio.”

The decision was telegraphed the moment the FDA advisory committee voted 12 to 1 against J&J’s filing, the discontinuation of the phase 3 trial of talacotuzumab came out of left field. Xencor, which provided the antibody technology behind talacotuzumab, learned in March that J&J had moved the drug into the phase 3 portion of its phase ⅔ AML trial. Now, J&J has discontinued the trial. J&J did not give a reasoning for their abrupt u-turn in its statement regarding the setback. The Big Pharma made no mention of trials in indications other than AML.

It is important to note that other CD123 drugs have encountered safety problems. J&J knows this well as the FDA has put J&J’s CD3-CD123 bispecific antibody JNJ-63709178 on clinical hold 13 months ago after a series of adverse events. CD123 has also targeted Cellectis’ CAR-T, it was hit with a clinical hold following the death of one of the first two patients to receive the therapy. It is also the target of Stemline Therapeutics SL-401, which was linked to patient deaths in a trial that is forging ahead following the implementation of steps to mitigate the safety concerns.

The information that J&J learned in the first seven months of phase 3 was enough to persuade them to scrap the trial, a decision that was not taken lightly. With sirukumab falling, J&J needs other drugs to step up and deliver the growth that it committed to in a bold presentation earlier in the year. The event saw J&J executives hail their products as “one of the most robust and sustainable in the industry” and talk up how it could redefine “the cyclical nature of our industry.” Now, two of J&J’s 11 anointed drugs have fallen, the robustness of the Big Pharma’s pipeline faces a challenge.

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