{"id":13647,"date":"2023-09-20T00:47:00","date_gmt":"2023-09-19T16:47:00","guid":{"rendered":"https:\/\/flcube.com\/?p=13647"},"modified":"2024-11-20T00:49:39","modified_gmt":"2024-11-19T16:49:39","slug":"pfizers-litfulo-earns-eu-approval-as-first-treatment-for-severe-alopecia-areata-in-teens","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13647","title":{"rendered":"Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens"},"content":{"rendered":"\n

Pfizer (NYSE: PFE<\/a>) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3\/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. This once-daily drug is the first to be approved in the region for this autoimmune disease, including teenage patients. The decision follows a positive opinion from the European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP).<\/p>\n\n\n\n

Approval Basis and Clinical Trial Results<\/strong>
The approval was grounded in long-term efficacy and safety data from an ongoing late-stage study, as well as results from a placebo-controlled Phase IIb\/III trial. The trial demonstrated that Litfulo significantly increased the rate of patients achieving 90% or more scalp hair coverage from 1.5% to 13.4%, and the rate of participants reporting moderate-to-great improvement increased from 9.2% to 49.2%.<\/p>\n\n\n\n

Global Approvals and Market Access<\/strong>
According to Pfizer, Litfulo has already received regulatory approval in Japan and the United States earlier this year, expanding access to this treatment for patients worldwide.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo…<\/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":[65,863,309,15],"class_list":["post-13647","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auto-immune","tag-nyse-pfe","tag-pfizer","tag-product-approvals"],"yoast_head":"\nPfizer's Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3\/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. 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