We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer's (PFE) Abrocitinib Betters Dupixent in Eczema Study
Read MoreHide Full Article
Pfizer (PFE - Free Report) announced that a phase III study comparing the efficacy of its investigational JAK inhibitor drug, abrocitinib to Sanofi (SNY - Free Report) /Regeneron’s (REGN - Free Report) blockbuster medicine, Dupixent (dupilumab) for moderate-to-severe atopic dermatitis (AD), met its co-primary and key secondary efficacy endpoints.
Top-line data from the head-to-head JADE DARE study showed that abrocitinib (200 mg administered as a once-daily oral tablet) was statistically superior compared to Dupixent (300 mg given as a subcutaneous injection every other week after a 600mg induction dose) in each evaluated efficacy measure. The study also showed that abrocitinib had a safety profile consistent with previous studies.
The study’s two primary endpoints were the proportion of patients achieving at least a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline at Week 2 and the proportion of patients achieving Eczema Area and Severity Index (EASI)-90 at Week 4.
Pfizer’s stock has risen 27.1% this year so far compared with an increase of 15.8% for the industry.
Image Source: Zacks Investment Research
A new drug application seeking approval of abrocitinib is under review with the FDA. However, the FDA has delayed its decision on the NDA twice due to the regulatory agency’s ongoing review of safety data from Pfizer’s post-marketing study, ORAL Surveillance, on its marketed JAK inhibitor medicine, Xeljanz in patients with rheumatoid arthritis.
The FDA has similarly delayed its decision on Pfizer’s supplemental NDA (sNDA) on Xeljanz for ankylosing spondylitis (AS). Similarly, the FDA has delayedthedecision on Lilly (LLY - Free Report) /Incyte and AbbVie’s 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 for the same reason.
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.
Image: Bigstock
Pfizer's (PFE) Abrocitinib Betters Dupixent in Eczema Study
Pfizer (PFE - Free Report) announced that a phase III study comparing the efficacy of its investigational JAK inhibitor drug, abrocitinib to Sanofi (SNY - Free Report) /Regeneron’s (REGN - Free Report) blockbuster medicine, Dupixent (dupilumab) for moderate-to-severe atopic dermatitis (AD), met its co-primary and key secondary efficacy endpoints.
Top-line data from the head-to-head JADE DARE study showed that abrocitinib (200 mg administered as a once-daily oral tablet) was statistically superior compared to Dupixent (300 mg given as a subcutaneous injection every other week after a 600mg induction dose) in each evaluated efficacy measure. The study also showed that abrocitinib had a safety profile consistent with previous studies.
The study’s two primary endpoints were the proportion of patients achieving at least a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline at Week 2 and the proportion of patients achieving Eczema Area and Severity Index (EASI)-90 at Week 4.
Pfizer’s stock has risen 27.1% this year so far compared with an increase of 15.8% for the industry.
Image Source: Zacks Investment Research
A new drug application seeking approval of abrocitinib is under review with the FDA. However, the FDA has delayed its decision on the NDA twice due to the regulatory agency’s ongoing review of safety data from Pfizer’s post-marketing study, ORAL Surveillance, on its marketed JAK inhibitor medicine, Xeljanz in patients with rheumatoid arthritis.
The FDA has similarly delayed its decision on Pfizer’s supplemental NDA (sNDA) on Xeljanz for ankylosing spondylitis (AS). Similarly, the FDA has delayedthedecision on Lilly (LLY - Free Report) /Incyte and AbbVie’s 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 for the same reason.
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.
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank(Strong Buy) stocks here.