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Pfizer (PFE) Gets CHMP Nod for JAK Inhibitor Abrocitinib
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Pfizer (PFE - Free Report) announced that it has received a positive recommendation from European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) for its investigational once-daily JAK1 inhibitor, abrocitinib, for the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy.
The CHMP’s recommendation is based on positive data from five phase III studies and a long-term extension study that evaluated abroticinib in more than 3,100 patients.
Please note that the regulatory filings for the drug are already under priority review with the FDA. Also, the drug has already received marketing authorization in the U.K. and Japan this year under the trade name Cibinqo.
In the year so far, the stock price of Pfizer has risen 12.7% in comparison with the industry’s 9.1% growth.
Image Source: Zacks Investment Research
The company also announced that the CHMP has recommended label expansion of its marketed JAK inhibitor Xeljanz (tofacitinib) for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
The recommendation from CHMP is based on positive data from the phase III study that evaluated the safety and efficacy of Xeljanz in comparison with placebo in active AS patients.
Please note that Xeljanz is currently approved in the EU for four indications - rheumatoid arthritis (RA), active psoriatic arthritis (PsA), ulcerative colitis (UC) and active polyarticular juvenile idiopathic arthritis (JIA).
Based on positive recommendations from CHMP, Pfizer anticipates potential approval for both its JAK inhibitors in their given indications by 2021-end. An application seeking approval of Xeljanz for AS is under review with the FDA.
JAK inhibitors have been in the spotlight in the United States. In September, the FDA issued a directive that the labels of three JAK inhibitor medicines — Xeljanz/Xeljanz XR, Lilly (LLY - Free Report) /Incyte’s (INCY - Free Report) Olumiant (baricitinib) and AbbVie’s (ABBV - Free Report) Rinvoq (upadacitinib) — approved to treat certain chronic inflammatory conditions should include warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death.
The decision came in the light of the completion of the review of safety data from Pfizer’s post-marketing study, ORAL Surveillance, on Xeljanz in patients with RA. The FDA’s review of the final data from the study showed that patients treated with both low and high doses of Xeljanz experienced a higher rate of serious heart-related events such as heart attack, stroke, cancer, blood clots, and death compared to those treated with TNF inhibitors. Previously, the FDA thought that only a higher dose of Xeljanz would increase such risks. The FDA required the warnings to be added not just to Xeljanz’s label but also on Olumiant (baricitinib) and Rinvoq (upadacitinib), even though no similar safety studies on these two medicines have been conducted. The FDA argued that since they share the same mechanism of action as Xeljanz, they may carry similar risks as identified in Xeljanz’s safety study.
Image: Bigstock
Pfizer (PFE) Gets CHMP Nod for JAK Inhibitor Abrocitinib
Pfizer (PFE - Free Report) announced that it has received a positive recommendation from European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) for its investigational once-daily JAK1 inhibitor, abrocitinib, for the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy.
The CHMP’s recommendation is based on positive data from five phase III studies and a long-term extension study that evaluated abroticinib in more than 3,100 patients.
Please note that the regulatory filings for the drug are already under priority review with the FDA. Also, the drug has already received marketing authorization in the U.K. and Japan this year under the trade name Cibinqo.
In the year so far, the stock price of Pfizer has risen 12.7% in comparison with the industry’s 9.1% growth.
The company also announced that the CHMP has recommended label expansion of its marketed JAK inhibitor Xeljanz (tofacitinib) for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
The recommendation from CHMP is based on positive data from the phase III study that evaluated the safety and efficacy of Xeljanz in comparison with placebo in active AS patients.
Please note that Xeljanz is currently approved in the EU for four indications - rheumatoid arthritis (RA), active psoriatic arthritis (PsA), ulcerative colitis (UC) and active polyarticular juvenile idiopathic arthritis (JIA).
Based on positive recommendations from CHMP, Pfizer anticipates potential approval for both its JAK inhibitors in their given indications by 2021-end. An application seeking approval of Xeljanz for AS is under review with the FDA.
JAK inhibitors have been in the spotlight in the United States. In September, the FDA issued a directive that the labels of three JAK inhibitor medicines — Xeljanz/Xeljanz XR, Lilly (LLY - Free Report) /Incyte’s (INCY - Free Report) Olumiant (baricitinib) and AbbVie’s (ABBV - Free Report) Rinvoq (upadacitinib) — approved to treat certain chronic inflammatory conditions should include warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death.
The decision came in the light of the completion of the review of safety data from Pfizer’s post-marketing study, ORAL Surveillance, on Xeljanz in patients with RA. The FDA’s review of the final data from the study showed that patients treated with both low and high doses of Xeljanz experienced a higher rate of serious heart-related events such as heart attack, stroke, cancer, blood clots, and death compared to those treated with TNF inhibitors. Previously, the FDA thought that only a higher dose of Xeljanz would increase such risks. The FDA required the warnings to be added not just to Xeljanz’s label but also on Olumiant (baricitinib) and Rinvoq (upadacitinib), even though no similar safety studies on these two medicines have been conducted. The FDA argued that since they share the same mechanism of action as Xeljanz, they may carry similar risks as identified in Xeljanz’s safety study.
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Pfizer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.