{"id":38023,"date":"2025-07-28T15:16:49","date_gmt":"2025-07-28T07:16:49","guid":{"rendered":"https:\/\/flcube.com\/?p=38023"},"modified":"2025-07-28T15:16:50","modified_gmt":"2025-07-28T07:16:50","slug":"sobi-north-americas-doptelet-approved-by-fda-for-pediatric-itp-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=38023","title":{"rendered":"Sobi North America’s Doptelet Approved by FDA for Pediatric ITP Treatment"},"content":{"rendered":"\n

Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi), announced today that the U.S. Food and Drug Administration (FDA) has approved Doptelet (avatrombopag) for the treatment of thrombocytopenia in pediatric patients aged one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior therapy. This approval also includes a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for use in children aged one to less than six years.<\/p>\n\n\n\n

Drug Mechanism and Warnings<\/strong>
Doptelet is a thrombopoietin (TPO) receptor agonist. TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or immune thrombocytopenia. Doptelet was first approved in the U.S. in May 2018 for the treatment of thrombocytopenia in adults with chronic liver disease. In 2019, Doptelet received U.S. approval for chronic immune thrombocytopenia in adults.<\/p>\n\n\n\n

License and Acquisition History<\/strong>
In March 2018, Fosun Pharma (600196.SH) licensed Doptelet from Dova Pharmaceuticals in the U.S. In September 2019, Swedish Orphan Biovitrum AB (STO:SOBI) acquired Dova Pharmaceuticals for $915 million, gaining the rights to Doptelet, with Sobi subsidiary AkaRx, Inc. taking the lead.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi), announced today…<\/p>\n","protected":false},"author":1,"featured_media":38025,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[68,15,4244],"class_list":["post-38023","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-pediatric-drugs","tag-product-approvals","tag-sobi-north-america"],"yoast_head":"\nSobi North America's Doptelet Approved by FDA for Pediatric ITP Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi), announced today that the U.S. Food and Drug Administration (FDA) has approved Doptelet (avatrombopag) for the treatment of thrombocytopenia in pediatric patients aged one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior therapy. 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