[{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer\u2019s Dupixent rival makes the grade in phase 3\u2014again","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase 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(Abrocitinib) for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Approves Pfizer\u2019s CIBINQO\u00ae (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Glenmark Pharmaceuticals","sponsor":"Pfizer Inc","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Glenmark Partners with Pfizer to Launch Abrocitinib in India to Treat Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Pfizer's Supplemental New Drug Application for CIBINQO\u00ae (abrocitinib)","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Abrocitinib
Under the partnership, Glenmark and Pfizer will co‐market abrocitinib, a Janus kinase 1 (JAK1) inhibitor, provides rapid itch relief and sustained disease control in India under the brand names Jabryus and Cibinqo, respectively.
CIBINQO (abrocitinib) is an oral inhibitor of Janus kinase 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
FDA approval for Cibinqo (Abrocitinib) JAK1 inhibitor, was based on the results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis.
The approval of Cibinqo (Abrocitinib) was based on the results of clinical studies for the treatment of moderate-to-severe atopic dermatitis (AD) in adults demonstrated meaningful improvements across measures of symptom relief.
Abrocitinib is oral small molecule that selectively inhibits JAK1. CHMP adopted positive opinion for marketing authorization to treat moderate to severe atopic dermatitis (AD), and CHMP also recommends XELJANZ® (tofacitinib) approval for treatment of ankylosing spondylitis.
Pfizer Inc today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for CIBINQO® (abrocitinib).
Abrocitinib 200mg was administered by once-daily oral tablet and dupilumab was administered by subcutaneous injection every other week following a 600mg induction dose.
Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis.
Patients were randomized into one of three arms: 200mg, 100mg, or placebo. Both doses of abrocitinib met the primary endpoint, resulting in significantly fewer patients experiencing flaring, compared to those randomized to placebo.
Filings based on robust abrocitinib clinical trial data demonstrating significant symptom improvement versus placebo as well as a consistent safety profile.
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