{"id":22395,"date":"2025-01-21T16:09:02","date_gmt":"2025-01-21T08:09:02","guid":{"rendered":"https:\/\/flcube.com\/?p=22395"},"modified":"2025-01-21T16:09:04","modified_gmt":"2025-01-21T08:09:04","slug":"arrowheads-plozasiran-accepted-for-fda-review-in-familial-chylomicronemia-syndrome","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22395","title":{"rendered":"Arrowhead’s Plozasiran Accepted for FDA Review in Familial Chylomicronemia Syndrome"},"content":{"rendered":"\n

US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR<\/a>) has announced that the New Drug Application (NDA) for its plozasiran, targeting familial chylomicronemia syndrome (FCS), has been accepted for review by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target date for the review is set for November 18, 2025. Market filings for plozasiran are also expected to be submitted to other regulatory bodies this year.<\/p>\n\n\n\n

Plozasiran: Mechanism and Development<\/strong>
Plozasiran is an APOC3-targeted siRNA therapy designed to effectively reduce serum triglyceride and triglyceride-rich lipoprotein levels through both lipoprotein lipase-dependent and independent pathways. The drug has previously been awarded orphan drug designation (ODD) and fast-track status in the US, as well as ODD in the European Union. Currently, plozasiran is being assessed in a Phase III study in adult FCS patients in China, where it has been granted breakthrough therapy designation and priority review status.<\/p>\n\n\n\n

Partnership and Global Reach<\/strong>
In April 2022, China-based Visirna Therapeutics secured the rights to plozasiran for Greater China through a licensing deal with Arrowhead. This partnership aims to accelerate the drug’s development and commercialization in the region, addressing the significant unmet medical needs of patients with FCS.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that the New Drug Application (NDA) for…<\/p>\n","protected":false},"author":1,"featured_media":22396,"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":[2396,38,2397,24],"class_list":["post-22395","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-arrowhead-pharmaceuticals","tag-market-approval-filings","tag-nasdaq-arwr","tag-rare-orphan-disease-drugs"],"yoast_head":"\nArrowhead's Plozasiran Accepted for FDA Review in Familial Chylomicronemia Syndrome - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that the New Drug Application (NDA) for its plozasiran, targeting familial chylomicronemia syndrome (FCS), has been accepted for review by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target date for the review is set for November 18, 2025. Market filings for plozasiran are also expected to be submitted to other regulatory bodies this year.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=22395\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Arrowhead's Plozasiran Accepted for FDA Review in Familial Chylomicronemia Syndrome\" \/>\n<meta property=\"og:description\" content=\"US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that the New Drug Application (NDA) for its plozasiran, targeting familial chylomicronemia syndrome (FCS), has been accepted for review by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target date for the review is set for November 18, 2025. 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