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CompilationFan Dongdong
At present, the entire JAK inhibitor series of drugs have encountered a chain reaction of negative safety signals from Pfizer Xeljanz
.
Now, another drug in this category is under more and more stringent scrutiny by the FDA
Incyte said on Tuesday that the FDA has postponed the approval date of the regulatory application for Jakafi for the treatment of steroid-refractory chronic graft-versus-host disease (GVHD) by 3 months.
Jakafi’s new target decision date for this indication is 9 On the 22nd
.
The delay in the Jakafi review date occurred after Incyte submitted additional test data in response to a recent FDA request
.
The drug maker said that the FDA sees this update as a major revision to Jakafi's previous package plan, so the regulatory agency said it now needs more time to review the drug
It is worth noting that Jakafi is not the first drug in the JAK inhibitor drug category to face delayed review by the FDA
.
Previously, the FDA postponed its rulings on Olumiant, a partnership between Eli Lilly and Incyte, and Pfizer's moderate to severe atopic dermatitis drug abrocitinib
The additional obstacles faced by the review of JAK inhibitors are mainly due to the serious safety issues observed in the post-marketing trials of Xeljanz in the treatment of rheumatoid arthritis
.
The study compared Pfizer JAK inhibitors with traditional TNF blockers.
At the end of 2011, Jakafi became the first JAK inhibitor approved by the FDA for the treatment of bone marrow disease myelofibrosis
.
Since May 2019, the drug has been approved for patients with steroid-refractory acute GVHD
Currently, Jakafi is administered twice a day with different intensities
.
Incyte is evaluating a once-daily formulation and is expected to be approved by the end of 2022
Reference source: Incyte the latest to fall victim to JAK scrutiny as FDA pushes back Jakafi review in GVHD
