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.
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