FDA Expands Dupixent Label to Include Efficacy Data in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis Involving Hands and/or Feet

▎WuXi

Edited by Kant Content Team

Regeneron Pharmaceuticals and Sanofi announced today that the U.S. FDA has updated its重磅Interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor Dupixent (dupilumab) for the treatment of atopic dermatitis (AD), adding efficacy and safety data for patients aged 12 years and older with moderate to severe atopic dermatitis whose hand and/or foot symptoms are uncontrolled. According to the press release,These Phase 3 data are derived from evaluations specifically targeting this refractory patient population.The FirstBiological Products Testing. In addition,Dupixent inThe EU label has also been updated, and regulatory applications in other countries/regions are ongoing.

This label update is primarily based on data from the LIBERTY-AD-HAFT Phase 3 clinical trial. In the trial, patients received Dupixent (n=67) or placebo (n=66) every two weeks. Analysis showed,More than twice as many patients in the Dupixent group achieved clear or almost clear skin compared to the placebo group, and nearly four times as many patients experienced improvement in itching.

Specifically,In the evaluation of the primary endpoint,At week 16, 40% of patients treated with Dupixent had clear or almost clear skin on their hands and feet, compared to only 17% in the placebo group.Additionally, in the assessment of key secondary endpoints, 52% of patients in the Dupixent group reported a clinically meaningful reduction in their hand and foot itching, compared to 14% in the placebo group.

Safety Results withDupixentPastTreatmentThe known safety of atopic dermatitis is generally consistent.DupixentThe most common adverse events (≥1%) including injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye itching, etc.

Dupixent is a fully humanized monoclonal antibody that inhibits signaling in the IL-4 and IL-13 pathways.Previously, Dupixent has been approved by the FDA for the treatment of diseases including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis, and eosinophilic esophagitis (EoE).

Notably, according to the industry media Endpoints,Regeneron expects to launch a small proof-of-concept study this year to evaluate the efficacy and safety of Dupixent in treating volunteers with severe food allergies.

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References:

[1] DUPIXENT® (DUPILUMAB) U.S. LABEL UPDATED WITH DATAFURTHER SUPPORTING USE IN ATOPIC DERMATITIS WITH MODERATE-TO-SEVERE HAND ANDFOOT INVOLVEMENT. Retrieved January 16, 2024 from https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-us-label-updated-data-further-supporting-use

[2] Looking past COPD, Regeneron CSO George Yancopoulos says Dupixent's'next big thing' is reversing allergies. Retrieved January 16, 2024 from https://endpts.com/regeneron-cso-george-yancopoulos-on-testing-dupixent-to-reverse-allergies/

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and (min-width:1024px) and (prefers-color-scheme:dark){body:not(.pages_skin_pc) .wx-root:not([data-weui-theme=light]),body:not(.pages_skin_pc) body:not([data-weui-theme=light]){--appmsgExtra-BG: #121212}}@media(prefers-color-scheme:dark){body:not([data-weui-theme=light]).my_comment_empty_data{background-color:#111}}body,.wx-root{--weui-BG-6: rgba(0, 0, 0, .05);--weui-ACTIVE-MASK: rgba(0, 0, 0, .05)}body,.wx-root{--weui-FG-1: rgba(0, 0, 0, .5);--weui-REDORANGE: #ff6146;--weui-BG-0: #ededed;--weui-BG-1: #f7f7f7;--weui-BG-2: #fff;--weui-BG-3: #f7f7f7;--weui-BG-4: #4c4c4c;--weui-BG-5: #fff;--weui-FG-0: rgba(0, 0, 0, .9);--weui-FG-HALF: rgba(0, 0, 0, .9);--weui-FG-1: rgba(0, 0, 0, .55);--weui-FG-2: rgba(0, 0, 0, .3);--weui-FG-3: rgba(0, 0, 0, .1);--weui-FG-4: rgba(0, 0, 0, .15);--weui-FG-5: rgba(0, 0, 0, .05);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #fa9d3b;--weui-YELLOW: #ffc300;--weui-GREEN: #91d300;--weui-LIGHTGREEN: #95ec69;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1485ee;--weui-PURPLE: #6467f0;--weui-WHITE: #fff;--weui-LINK: #576b95;--weui-TEXTGREEN: #06ae56;--weui-FG: #000;--weui-BG: #fff;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: #fa9d3b;--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: #06ae56;--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: #10aeff;--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(0, 0, 0, .5);--weui-TAG-BACKGROUND-BLACK: rgba(0, 0, 0, .05)}body,.wx-root{--weui-BG-0: #ededed;--weui-BG-1: #f7f7f7;--weui-BG-2: #fff;--weui-BG-3: #f7f7f7;--weui-BG-4: #4c4c4c;--weui-BG-5: #fff;--weui-FG-0: rgba(0, 0, 0, .9);--weui-FG-HALF: rgba(0, 0, 0, .9);--weui-FG-1: rgba(0, 0, 0, .55);--weui-FG-2: rgba(0, 0, 0, .3);--weui-FG-3: rgba(0, 0, 0, .1);--weui-FG-4: rgba(0, 0, 0, .15);--weui-FG-5: rgba(0, 0, 0, .05);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #fa9d3b;--weui-YELLOW: #ffc300;--weui-GREEN: #91d300;--weui-LIGHTGREEN: #95ec69;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1485ee;--weui-PURPLE: #6467f0;--weui-WHITE: #fff;--weui-LINK: #576b95;--weui-TEXTGREEN: #06ae56;--weui-FG: #000;--weui-BG: #fff;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: #fa9d3b;--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: #06ae56;--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: #10aeff;--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(0, 0, 0, .5);--weui-TAG-BACKGROUND-BLACK: rgba(0, 0, 0, .05)}.wx-root,body{--weui-BTN-ACTIVE-MASK: rgba(0, 0, 0, .1)}.wx-root,body{--weui-BTN-DEFAULT-ACTIVE-BG: #e6e6e6}.wx-root,body{--weui-DIALOG-LINE-COLOR: rgba(0, 0, 0, .1)}.wx-root,body{--weui-BG-COLOR-ACTIVE: 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#373737}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-BG-6: rgba(255, 255, 255, .1);--weui-ACTIVE-MASK: rgba(255, 255, 255, .1)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-REDORANGE: #ff6146;--weui-BG-0: #111;--weui-BG-1: #1e1e1e;--weui-BG-2: #191919;--weui-BG-3: #202020;--weui-BG-4: #404040;--weui-BG-5: #2c2c2c;--weui-FG-0: rgba(255, 255, 255, .8);--weui-FG-HALF: rgba(255, 255, 255, .6);--weui-FG-1: rgba(255, 255, 255, .5);--weui-FG-2: rgba(255, 255, 255, .3);--weui-FG-3: rgba(255, 255, 255, .1);--weui-FG-4: rgba(255, 255, 255, .15);--weui-FG-5: rgba(255, 255, 255, .1);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #c87d2f;--weui-YELLOW: #cc9c00;--weui-GREEN: #74a800;--weui-LIGHTGREEN: #3eb575;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1196ff;--weui-PURPLE: #8183ff;--weui-WHITE: rgba(255, 255, 255, .8);--weui-LINK: 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174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--appmsgExtra-BG: #121212}}h1,h2,h3,h4,h5,h6{font-weight:400;font-size:16px}.rich_media_content p{clear:both;min-height:1em}td p{margin:0;padding:0}@media screen and (min-width:1024px){body:not(.pages_skin_pc) :root{--appmsgPageGap: 20px;--appmsgPageBottomGap: 40px}}:root{--articleFontsize: 17px}:root{--sab: env(safe-area-inset-bottom)}:root{--wxBorderAvatarRatio: 3}:root{--discussPageGap: 20px}:root{--appmsgPageGap: 20px;--appmsgPageBottomGap: 40px}@media(prefers-color-scheme:dark){body:not([data-weui-theme=light]) .rich_media_content img:not(.wx_img_placeholder){filter:brightness(.8)}}*{margin:0;padding:0}.rich_media_content 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div.autoTypeSetting24psection > p,div.autoTypeSetting24psection > section{margin-bottom: 24px;}