Recently, Johnson and Johnson (JNJ) drug sirukumab was voted down in an advisory panel. The panel recommended against approval by an overwhelming majority. The main issue with the drug had to do with patient safety. That is why the panel did not want to recommend approve for the drug. I feel that this is a big setback for Johnson & Johnson, but not all is lost yet. It will still take time to get the drug to market, but it could be a long road ahead.
The advisory panel overseeing the recommendation for sirukumab approval was the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA). The panel voted 12 to 1 against the recommendation for approval of sirukumab in patients with moderate to severe rheumatoid arthritis. The reasoning for denying recommendation for the drug was because of safety concerns. The panel noted that there were a huge imbalance of patient deaths in the trials. With this concern, the panel wasn't up for approving the drug with minimal safety data. So what was the concern with the overall safety data? The issue was that out of the 35 deaths that had occurred within 16 weeks of the final dose, 34 of the deaths involved patients who had received sirukumab. The cause of death for these patients were cardiovascular disease, and major infections. Johnson & Johnson didn't seem to have enough safety data on hand to sway these panelists towards its favor.