Abbvie Inc (ABBV)

[DewDiligence]

ABBV -8% on_new_FDA-label_warnings_for JAK inhibitors_including Rinvoq:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death

This update affects other JAK inhibitors approved, or seeking approval, for inflammatory diseases: PFE’s Xeljanz and Abrocitinib; and LLY/INCY’s Olumiant. The update does not affect JAK inhibitors approved for other indications, and it does not affect TYK2 inhibitors such as BMY’s Deucravacitinib.

The FDA’s safety review of the JAK class in inflammatory diseases was triggered by the results of a Xeljanz long-term safety study reported in Jan 2021 (#msg-161253317).

ABBV is affected so strongly by today’s FDA action because Rinvoq was expected to become a mega-blockbuster, cushioning the blow from Humira’s looming patent expiration.