The Dermatology Digest
DECEMBER 27, 2024
Johnson & Johnson has entered into an exclusive licensing agreement for the global development, manufacturing and commercialization of a STAT6 program for autoimmune and allergic diseases, including atopic dermatitis (AD), from Kaken Pharmaceutical.
The Dermatology Digest
OCTOBER 28, 2024
The FDA is reviewing a supplemental New Drug Application (sNDA) for tapinarof cream, 1%, as a potential treatment for atopic dermatitis (AD) in adults and children two years of age and older, with Prescription Drug User Fee Act (PDUFA) action expected in the fourth quarter of calendar year 2024.
The Dermatology Digest
MARCH 5, 2024
Pharmacokinetic (PK) data showed a half-life of approximately 75 days across doses tested and pharmacodynamic (PD) data showed, deep and sustained inhibition of key atopic dermatitis (AD) biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available, with inhibition still ongoing at time of the data cut).
The Dermatology Digest
DECEMBER 5, 2024
Apogee Therapeutics recently hosted its first R&D Day, which featured updates across its entire portfolio. Some of the key highlights related to atopic dermatitis (AD) therapies include: APG777 APG777 is a novel, subcutaneous, extended half-life monoclonal antibody (mAb) targeting interleukin (IL)-13.
The Dermatology Digest
FEBRUARY 26, 2025
Food and Drug Administration (FDA) accepted Arcutis Supplemental New Drug Application (sNDA) for roflumilast cream 0.05% (Zoryve) for the treatment of children aged 2 to 5 with mild-to-moderate atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) target action date is set for October 13, 2025. At Week 4, 25.4%
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