New label warnings raise hopes for Jak safety closure

The full fallout from the FDA’s safety review of the Jak inhibitors remains unknown, amid concerns about moves to curb these drugs’ use drastically. But two label updates that emerged late Friday are raising hopes that draconian measures are off the table. Abbvie and Pfizer announced new boxed warnings for their respective products, Rinvoq and Xeljanz. These black boxes now highlight the higher rate of major adverse cardiac events seen versus anti-TNF agents in the Oral Surveillance trial of Xeljanz. As expected, both have also had rheumatoid arthritis indications scaled back, with patients required to have failed at least one TNF blocker. Analysts believe that Abbvie has come off as well as could be expected, with the label wording making it clear that the Mace signal was seen with “another Jak inhibitor”, and no restrictions on duration of use; some were expecting harsher action from the regulator. Still, several approvals are pending for Rinvoq and others, and a tougher line in less life-limiting settings, like atopic dermatitis, cannot be ruled out. Whatever the outcome, the potential of these agents has surely already been curtailed, which was the probably the FDA’s goal in the first place.