The JADE REGIMEN trial was a responder-enriched, placebo-controlled withdrawal study that included a 12-week open-label run-in period.
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The approval was based on data from previous studies that included 124 adolescent patients, as well as the phase 3 JADE TEEN study.
Positive topline results were announced from the phase 3 JADE TEEN study evaluating abrocitinib (Pfizer), a Janus Kinase (JAK) inhibitor, in patients aged 12 to <18 years with moderate to severe atopic dermatitis who were also on background topical therapy.
Top-line results were announced from a phase 3 study evaluating the safety and efficacy of abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis in patients ≥12 years old.
Pfizer announced positive topline results from the phase 3 JADE MONO-2 trial of abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). The multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of abrocitinib in 391 patients aged ≥12 years with a minimum body weight of…
The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.
The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of February. The chart below provides highlights of key monograph updates made this month (not an inclusive list). Click on the name of the drugs to view the full monographs on eMPR.com. Key: D=Dosing,…
Updated on 6/16 While no specific treatment for coronavirus disease 2019 (COVID-19) is currently available, several therapies are being investigated globally.* AB201 (ARCA biopharma): a selective inhibitor of tissue factor being developed as a potential treatment for COVID associated coagulopathy. Clinical testing is expected to begin in the second half of 2020. Acalabrutinib (AstraZeneca): a…
Review the January 2022 notable drug approvals.
Currently, there are no antivirals licensed by the FDA to treat patients with COVID-19.