Pfizer ( PFE Quick Quote PFE - Free Report) announced that the European Commission (EC) has granted approval to its JAK inhibitor drug, Xeljanz for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular JIA) and juvenile psoriatic arthritis (juvenile PsA). The approval of two formulations, a tablet and an oral solution, is for patients who are at least two years of age and who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs)
With the latest approval, Xeljanz is now approved for four indications in the EU, rheumatoid arthritis (RA), active PsA, moderately to severely active ulcerative colitis (UC) and now polyarticular JIA and juvenile PsA.
Pfizer’s stock has risen 32.4% this year so far compared with an increase of 19.3% for the
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In the United States, Xeljanz is presently approved for four indications, RA, active PsA, UC and active polyarticular course juvenile idiopathic arthritis. An application seeking approval of Xeljanz for ankylosing spondylitis (AS) is under review with the FDA. However, last month, the FDA informed that it will not be able to meet the PDUFA date for sNDA seeking approval of Xeljanz for the AS indication. The FDA also delayed the decision on Pfizer’s investigational medicine, abrocitinib for moderate-to-severe atopic dermatitis (AD). The FDA was expected to give its decision on the NDA in the third quarter of 2021.
This is the second time that the FDA has delayed its decision on Pfizer’s NDA for abrocitinib for AD and Xeljanz’s sNDA for AS due to its ongoing review of safety data from Pfizer’s post-marketing study, ORAL Surveillance, on Xeljanz in patients with rheumatoid 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.
In the second quarter, Xeljanz sales declined 9% to $586 million due to unfavorable change in channel mix and lower new patient starts due to FDA’s ongoing review.
The FDA has also delayed decision on
Lilly ( LLY Quick Quote LLY - Free Report) / Incyte ( INCY Quick Quote INCY - Free Report) and AbbVie’s ( ABBV Quick Quote ABBV - Free Report) sNDA seeking approval of their respective JAK inhibitor drugs, Olumiant (baricitinib) and Rinvoq (upadacitinib) for AD and also sNDAs on Rinvoq for active psoriatic arthritis and active ankylosing spondylitis in adults.
The FDA has cited its ongoing review of Pfizer’s post-marketing study, ORAL Surveillance, on Xeljanz (tofacitinib), as discussed above, as the reason for all the above delays.
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.
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