Pfizer ( PFE Quick Quote PFE - Free Report) announced that the FDA has extended the review timeline of its new drug application (NDA) for its pipeline candidate, abrocitinib by three months.
The NDA sought approval of abrocitinib, an oral JAK inhibitor, for the treatment of adults and adolescents with moderate-to-severe atopic dermatitis (AD).
The FDA also extended the review period for Pfizer’s supplemental NDA (sNDA) seeking approval of its marketed JAK inhibitor, Xeljanz for the treatment of active ankylosing spondylitis (AS) by three months. The FDA’s decision on both the applications is now expected early in the third quarter of 2021.
Xeljanz is presently approved to treat four indications — rheumatoid arthritis (RA), active psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
We remind investors that in February, the FDA issued a statement that Xeljanz may increase the risk of heart-related problems and cancer. The statement was based on data from a study that compared the drug to another class of drugs — tumor necrosis factor inhibitors. The post-marketing safety study on Xeljanz in patients with RA failed to show non-inferiority of Xeljanz to a TNF inhibitor with regard to major adverse cardiovascular events and malignancies. The FDA had required Pfizer to conduct this study as a condition of Xeljanz’s approval.
Xeljanz generated sales of $2.4 million in 2020, recording an increase of 9% year over year.
Pfizer’s shares have declined 2.4% this year so far compared with the
industry’s decline of 0.9%.
We remind investors that recently the FDA also extended the review timeline for two sNDAs for
AbbVie’s ( ABBV Quick Quote ABBV - Free Report) JAK inhibitor drug, Rinvoq (upadacitinib) by three months. The sNDAs sought approval for Rinvoq for atopic dermatitis and active psoriatic arthritis. Rinvoq is presently approved for treating moderate-to-severe rheumatoid arthritis. Earlier this week, the FDA extended the review timeline for Lilly ( LLY Quick Quote LLY - Free Report) and partner Incyte’s ( INCY Quick Quote INCY - Free Report) sNDA for their oral JAK inhibitor, Olumiant in atopic dermatitis also by three months.
The extension of review periods for sNDAs and other negative updates for JAK inhibitor drugs have raised concerns regarding safety issues of this class of drugs. JAK inhibitors work by blocking a particular signal of a body’s immune response, cytokines, instead of suppressing the immune system as done by DMARDs. However, this class of drugs come with their share of side effects including risk of serious infections, malignancies and thrombosis. Some of these side effects are mentioned as boxed warnings in labels of these JAK inhibitor drugs.
Pfizer currently has a Zacks Rank #3 (Hold). You can see
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