{"id":1713,"date":"2024-07-15T09:13:30","date_gmt":"2024-07-15T01:13:30","guid":{"rendered":"https:\/\/flcube.com\/?p=1713"},"modified":"2024-10-15T14:37:19","modified_gmt":"2024-10-15T06:37:19","slug":"huadong-medicines-partner-arcutis-gets-fda-nod-for-roflumilast-cream","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=1713","title":{"rendered":"Huadong Medicine’s Partner Arcutis Gets FDA Nod for Roflumilast Cream"},"content":{"rendered":"\n

Huadong Medicine Co., Ltd (SHE: 000963<\/a>), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT<\/a>), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). This clearance is for treating mild to moderate atopic dermatitis (AD) in adults and children aged six and above.<\/p>\n\n\n\n

The approval follows successful clinical trials, including the Phase III INTEGUMENT-1 and INTEGUMENT-2 studies, which met their primary endpoint of IGA success. This indicates that vIGA AD was rated as “cleared” or “essentially cleared,” showing a 2-point improvement from baseline at week 4. Zoryve cream demonstrated a rapid and significant reduction in itching within 24 hours of the initial application compared to the placebo. Over 40% of the treated subjects achieved EASI-75 by the fourth week, a significant improvement over the approximately 20% in the placebo group. The cream also exhibited good overall tolerability.<\/p>\n\n\n\n

Roflumilast, the active ingredient in Zoryve, is a phosphodiesterase4 (PDE4) inhibitor that modulates the production of pro-inflammatory mediators and anti-inflammatory agents. It is already approved in the U.S. for the treatment of AD, seborrheic dermatitis, and plaque psoriasis.<\/p>\n\n\n\n

In August 2023, Huadong Medicine secured an exclusive licensing deal worth USD 94.25 million with Arcutis, covering Daxas (roflumilast, including cream Zoryve and foam agent ARQ-154) for external preparations in Greater China and South-East Asia.- Flcube.com<\/a><\/p>\n\n\n\n

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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[125,114,1253,15,887],"class_list":["post-1713","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-arcutis-biotherapeutics","tag-huadong-medicine","tag-nasdaq-arqt","tag-product-approvals","tag-she-000963"],"yoast_head":"\nHuadong Medicine's Partner Arcutis Gets FDA Nod for Roflumilast Cream - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). 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