The approval of the drug
The report was published two days before a committee of outside advisors were scheduled to meet in order to have a discussion about sirukumab and to decide whether or not it should be approved. While the FDA is not required to follow the recommendations of advisors, they typically rely on their information when deciding whether or not to approve drugs.
The most common causes of death among those who took sirukumab included infection, malignancies, and major heart problems. The report that was published on the FDA website stated that while the other safety concerns seemed similar to other drugs in the same class, the issue of death seemed isolated to those who took sirukumab.