As discussed in my previous post, Pfizer agreed this week to pay US$6.7bn to acquire the clinical-stage inflammatory disease drug pipeline of Arena Pharmaceuticals. Arena’s lead drug candidates, which target sphingosine-1-phosphate or S1P, will be added to Pfizer’s portfolio of JAK inhibitors, led by Xeljanz. Sales of Xeljanz in 2020 were US$2.5bn.
Also this week, the FDA approved both Pfizer’s Xeljanz, and AbbVie’s JAK inhibitor, Rinvoq, in the treatment of ankylosing spondylitis and psoriatic arthritis respectively. While this is the fifth indication for which the FDA has approved Xeljanz, as with its other indications, labelling must include safety warnings and approval is restricted to use as a second-line treatment.
The reason for this stance is safety. In September, the FDA announced the results of a large randomized safety trial of Xeljanz in which the drug’s safety profile was compared with TNF blockers (such as Humira and Enbrel). It was concluded that there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with use of Xeljanz, including at a lower dose. Consequently, the FDA issued a directive requiring new and updated warnings for Xeljanz and two other JAK inhibitors, Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib).
As the cloud builds over JAK inhibitors, Pharmorage’s two new approaches to treating inflammation are likely to garner strong interest.
https://endpts.com/amid-safety-conc...t-with-added-warnings-and-a-key-label-change/
https://www.fiercepharma.com/market...bbvie-s-rinvoq-pfizer-s-xeljanz-as-jak-safety
https://www.fda.gov/drugs/drug-safe...t-related-events-cancer-blood-clots-and-death
