{"id":12517,"date":"2023-10-25T22:51:00","date_gmt":"2023-10-25T14:51:00","guid":{"rendered":"https:\/\/flcube.com\/?p=12517"},"modified":"2024-11-13T23:11:27","modified_gmt":"2024-11-13T15:11:27","slug":"bmss-bms-986278-receives-fda-breakthrough-therapy-designation-for-pulmonary-fibrosis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12517","title":{"rendered":"BMS’s BMS-986278 Receives FDA Breakthrough Therapy Designation for Pulmonary Fibrosis"},"content":{"rendered":"\n

Bristol-Myers Squibb (BMS; NYSE: BMY<\/a>) announced this week that it has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for BMS-986278, its potential first-in-class lysophosphatidic acid receptor 1 (LPA1) antagonist. This oral treatment for progressive pulmonary fibrosis (PPF) is now set for expedited development and review, a significant step forward in addressing this life-threatening disease.<\/p>\n\n\n\n

Phase II Trial Results<\/strong>
The FDA’s decision is based on promising results from a Phase II trial, which demonstrated that BMS-986278 was well tolerated and resulted in a 69% relative reduction in percent-predicted forced vital capacity (ppFVC) decline compared to placebo. These findings highlight the drug’s potential to significantly slow the progression of PPF, a condition characterized by the hardening and thickening of lung tissue.<\/p>\n\n\n\n

Previous Regulatory Milestones<\/strong>
BMS-986278 has previously been awarded fast-track and orphan drug designations by the FDA for idiopathic pulmonary fibrosis (IPF), a related condition. These designations, along with the recent breakthrough therapy designation, underscore the regulatory commitment to facilitating the development and approval of new treatments for patients with limited therapeutic options.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

Bristol-Myers Squibb (BMS; NYSE: BMY) announced this week that it has received breakthrough therapy designation…<\/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":[429,428,849,25],"class_list":["post-12517","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-bms","tag-bristol-myers-squibb","tag-nyse-bmy","tag-potential-first-in-class"],"yoast_head":"\nBMS's BMS-986278 Receives FDA Breakthrough Therapy Designation for Pulmonary Fibrosis - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Bristol-Myers Squibb (BMS; NYSE: BMY) announced this week that it has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for BMS-986278, its potential first-in-class lysophosphatidic acid receptor 1 (LPA1) antagonist. 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