FDA

FDA slams J&J’s blockbuster contender sirukumab on ‘important safety risks’

Just days after GlaxoSmithKline dumped its partnership with J&J on the late-stage rheumatoid arthritis drug sirukumab, the FDA helped illustrate why the pharma giant was ready to bail at this late date.

In an internal review out two days ahead of a scheduled panel review, regulators spotlighted a troubling round of safety data for the IL-6 drug, which has provided only mixed efficacy results so far. According to the review, there was a clear imbalance in deaths and malignancies among the patients studied over a 52-week period.

From the review:

Wide confidence intervals around treatment comparisons for serious rare events such as death, malignancy, and MACE indicate that the imbalances could be due to chance but also that relatively large increases in risks on sirukumab cannot be ruled out based on the data alone. Such imbalances raise concern regarding these important safety risks. Additional safety signals related to events of GI perforation and hypersensitivity were also observed.

Ominously, the review also highlights alternative RA therapies, raising additional questions why the agency would green-light a drug with potential safety issues for a huge market.

Highlighting the agency’s stance on rheumatoid arthritis drugs, Eli Lilly revealed last week that the FDA had rejected its big blockbuster contender baricitinib after a handful of blood clots were seen in the drug arms of the comparative studies done.

In the meantime, Regeneron and Sanofi have strutted ahead to win a delayed OK on sarilumab while AbbVie works on its own successor to Humira, ABT-494. And Gilead is moving confidently ahead with a massive Phase III program for filgotinib.

J&J, though, isn’t about to give up at this point. In a statement, the company said:

Patient well-being is our highest priority at Janssen and we take the safety of all patients participating in our clinical programs very seriously.  We recognize the complexity and seriousness of a disease like rheumatoid arthritis (RA) and the tremendous needs that remain for new treatment alternatives as patients living with RA often cycle through multiple therapies until finding one that may work for them.  We are confident in the benefit-to-risk of sirukumab and look forward to meeting with the Arthritis Advisory Committee to review efficacy and safety data supporting the proposed indication for the treatment of moderately to severely active RA.

We’ll find out more at the panel review on Wednesday.


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RAPS Regulatory Convergence 2017