Since the February 2021 FDA alert about Xeljanz-associated heart problems and possible Xeljanz-related cancers was issued, we have been watching for any related drug safety developments concerning Olumiant and Rinvoq. The reason being there has been some concern that those adverse drug events and side effects risks may apply to those other two Janus kinase (JAK) inhibitors, also. Put otherwise, are heart problems and cancers to be viewed as JAK inhibitors drug class safety issues?
One indication of this concern is found in a March 18, 2021, BioPharma news report, “AbbVie’s approval delay raises further concerns about JAK drugs”, from which we get the following:
The Food and Drug Administration may take up to three months longer to review an application from AbbVie to get Rinvoq, its marketed medicine for rheumatoid arthritis, also approved to treat active psoriatic arthritis. The company now expects a decision toward the end of the second quarter.
AbbVie gave few details about the reasons for the delay in a Wednesday statement, noting only that the FDA had requested new information on the drug’s benefits and risks in psoriatic arthritis patients. But after speaking with the company, Vamil Divan, an analyst at Mizuho Securities, learned the requests were for long-term safety data similar to what Pfizer recently showed for Xeljanz, a rival drug that works like Rinvoq.
We will continue to watch for newly released information from the Xeljanz safety clinical trial that showed Xeljanz-associated heart problems and possible Xeljanz-related cancers and which is the basis for the February 2021 Xeljanz FDA Drug Safety Communication. In addition, for the reasons stated above, we will monitor the safety profile of Rinvoq and Olumiant to see whether those are JAK inhibitors drug class adverse drug events and side effects risks.[View article at original source]