FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis

Pfizer Inc. announced that the FDA accepted for filing and granted Priority Review designation to the company’s New Drug Application for abrocitini, an investigational oral once-daily Janus kinase 1 inhibitor, for the treatment of moderate to severe atopic dermatitis in patients 12 and older.
[Pfizer Inc. (BusinessWire, Inc.)]
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CHMP Recommends Approval of Dupixent® (Dupilumab) for Children Aged 6 to 11 Years with Severe Atopic Dermatitis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent®, recommending to extend the approval in the European Union to include children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy.
[CHMP (Globe Newswire LLC)]
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AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ (upadacitinib) in Atopic Dermatitis

AbbVie announced that it submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe atopic dermatitis.
[AbbVie]
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Evelo Biosciences Completes Enrollment in Phase Ib Clinical Trial Cohort Evaluating EDP1815 in Atopic Dermatitis

Evelo Biosciences, Inc. completed enrollment of 24 patients in the Phase Ib clinical trial cohort evaluating EDP1815 in mild to moderate atopic dermatitis. EDP1815 is an investigational oral biologic in development for the treatment of inflammatory diseases
[Evelo Biosciences, Inc.]
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Derm-Biome Pharmaceuticals, Inc. Reports Positive Results from a Preclinical Study In Psoriasis

Derm-Biome Pharmaceuticals, Inc, announced that one of its topical drugs produced significant, and dose dependent inhibitory effects in a well established mouse model of psoriasis.
[Derm-Biome Pharmaceuticals, Inc, (Globe Newswire LLC)]
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Staphylococcus aureus Second Immunoglobulin-Binding Protein Drives Atopic Dermatitis via IL-33

In vitro human keratinocyte cell culture, ex vivo human skin organ explants and the eczema prone Nc/Tnd mouse were used as model systems to assess type-2 promoting immune responses to S. aureus.
[Journal of Allergy and Clinical Immunology]
Kindi, A. A., Williams, H., Matsuda, K., Alkahtani, A. M., Saville, C., Bennett, H., Alshammari, Y., Tan, S. Y., O’Neill, C., Tanaka, A., Matsuda, H., Arkwright, P. D., & Pennock, J. L. (2020). Staphylococcus aureus Second Immunoglobulin-Binding Protein drives atopic dermatitis via IL-33. Journal of Allergy and Clinical Immunology, 0(0). https://doi.org/10.1016/j.jaci.2020.09.023 Cite
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CHMP Recommends Approval of Lilly’s Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis

Eli Lilly and Company and Incyte announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis who were candidates for systemic therapy.
[Eli Lilly and Company]
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Arcutis Biotherapeutics to Accelerate ARQ-151 (Topical Roflumilast Cream) into Phase III Trials for the Treatment of Atopic Dermatitis Following End-of-Phase II Meeting with FDA

Arcutis Biotherapeutics, Inc. announced plans to advance its program to develop ARQ-151 for the treatment of atopic dermatitis into Phase III clinical trials following its End-of-Phase II meeting with the FDA, without conducting the previously planned Phase IIb atopic dermatitis trial.
[Arcutis Biotherapeutics, Inc.]
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Costello Syndrome Model Mice with a Hras G12S Mutation Are Susceptible to Develop House Dust Mite-Induced Atopic Dermatitis

Cultured HrasG12S/+ keratinocytes exhibited increased IL-33 expression after Dermatophagoides farinae stimulation.
[Cell Death & Disease]
Katata, Y., Inoue, S., Asao, A., Kobayashi, S., Terui, H., Inoue-Shibui, A., Abe, T., Niihori, T., Aiba, S., Ishii, N., Kure, S., & Aoki, Y. (2020). Costello syndrome model mice with a Hras G12S mutation are susceptible to develop house dust mite-induced atopic dermatitis. Cell Death & Disease, 11(8), 1–15. https://doi.org/10.1038/s41419-020-02845-8 Cite
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Disease-Associated KIF3A Variants Alter Gene Methylation and Expression Impacting Skin Barrier and Atopic Dermatitis Risk

Researchers found that KIF3A SNP rs11740584 and rs2299007 risk alleles created cytosine-phosphate-guanine sites, which were highly methylated and resulted in lower KIF3A expression.
[Nature Communications]
Stevens, M. L., Zhang, Z., Johansson, E., Ray, S., Jagpal, A., Ruff, B. P., Kothari, A., He, H., Martin, L. J., Ji, H., Wikenheiser-Brokamp, K., Weirauch, M. T., Supp, D. M., Biagini Myers, J. M., & Khurana Hershey, G. K. (2020). Disease-associated KIF3A variants alter gene methylation and expression impacting skin barrier and atopic dermatitis risk. Nature Communications, 11(1), 4092. https://doi.org/10.1038/s41467-020-17895-x Cite
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The Role of Kallikreins in Inflammatory Skin Disorders and their Potential as Therapeutic Targets

The authors highlight the roles of kallikreins in skin homeostasis and pathologies. Due to their part in these skin disorders, inhibitors of the skin kallikreins have become attractive therapeutics.
[Critical Reviews in Clinical Laboratory Sciences]
The role of kallikreins in inflammatory skin disorders and their potential as therapeutic targets: Critical Reviews in Clinical Laboratory Sciences: Vol 0, No 0. (n.d.). Retrieved June 24, 2020, from https://www.tandfonline.com/doi/abs/10.1080/10408363.2020.1775171?journalCode=ilab20 Cite
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