{"id":10471,"date":"2019-10-25T11:14:23","date_gmt":"2019-10-25T05:44:23","guid":{"rendered":"https:\/\/www.rootsanalysis.com\/blog\/?p=10471"},"modified":"2026-07-27T13:29:49","modified_gmt":"2026-07-27T07:59:49","slug":"gene-therapy-pipeline-update-avrobio-receives-orphan-drug-designation","status":"publish","type":"post","link":"https:\/\/www.rootsanalysis.com\/blog\/gene-therapy-pipeline-update-avrobio-receives-orphan-drug-designation\/","title":{"rendered":"Gene Therapy Pipeline Update: AVROBIO Receives Orphan-Drug Designation"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">AVROBIO, a US-based company, developing lentiviral-based gene therapies, has announced that the&nbsp;U.S. Food and Drug Administration&nbsp;(FDA) has granted orphan-drug designation for the Company\u2019s investigational gene therapy, AVR-RD-02, for the treatment of <a href=\"https:\/\/emedicine.medscape.com\/article\/944157-overview\">Gaucher disease<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What is AVR-RD-02<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">AVR-RD-02 consists of the patient\u2019s own hematopoietic stem cells, genetically modified to express glucocerebrosidase (GCase), the enzyme that is deficient in Gaucher disease. It\u00a0is an\u00a0<i>ex vivo<\/i>\u00a0lentiviral-based investigational gene therapy. The stem cells are genetically modified to express functional glucocerebrosidase (GCase), which reduces levels of glucosylceramide and glucosylsphingosine, the accumulated substances which cause the symptoms of Gaucher disease.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How advanced is AVR-RD-02 development program<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The Company is actively recruiting in\u00a0<a href=\"https:\/\/gaucherdiseasenews.com\/2018\/10\/02\/health-canada-oks-avrobio-request-advance-avr-rd-02-into-clinical-trials\/\">Canada<\/a>\u00a0for its Phase 1\/2 clinical trial of AVR-RD-02, which seeks to evaluate the safety and efficacy of the therapy in patients with Type 1 Gaucher disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What is an orphan drug designation<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Orphan-drug designation provides special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.\u00a0For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA\u2019s implementing regulations at\u00a021 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Check out the detailed news here.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What is the gene therapy pipeline like for the treatment of Gaucher disease<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00a0<\/strong>There are only a few gene therapy candidates that are being developed for Gaucher disease.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"566\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Gene-Therapy-for-Gaucher-Disease-Roots-1024x566.webp\" alt=\"Gene Therapy Pipeline Update from Roots Analysis shows distribution by various stages of trials for Gaucher disease\" class=\"wp-image-17690\" style=\"object-fit:contain;width:800px;height:444px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Gene-Therapy-for-Gaucher-Disease-Roots-1024x566.webp 1024w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Gene-Therapy-for-Gaucher-Disease-Roots-300x166.webp 300w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Gene-Therapy-for-Gaucher-Disease-Roots-768x424.webp 768w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Gene-Therapy-for-Gaucher-Disease-Roots-1536x849.webp 1536w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Gene-Therapy-for-Gaucher-Disease-Roots.webp 1658w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">For detailed insights about the gene therapy market landscape, check out the report <a href=\"https:\/\/www.rootsanalysis.com\/reports\/gene-therapies-market\/268.html\">Gene Therapy Market report<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>AVROBIO, a US-based company, developing lentiviral-based gene therapies, has announced that the&nbsp;U.S. Food and Drug Administration&nbsp;(FDA) has granted orphan-drug designation for the Company\u2019s investigational gene therapy, AVR-RD-02, for the treatment of Gaucher disease. What is AVR-RD-02 AVR-RD-02 consists of the patient\u2019s own hematopoietic stem cells, genetically modified to express glucocerebrosidase (GCase), the enzyme that is [&hellip;]<\/p>\n","protected":false},"author":21,"featured_media":17281,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[47],"tags":[332,48],"class_list":["post-10471","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gene-therapy","tag-avrobio","tag-gene-therapy"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Gene Therapy: AVROBIO Receives Orphan-Drug Designation<\/title>\n<meta name=\"description\" content=\"AVROBIO, a US-based company, developing lentiviral-based gene therapy, has announced that the U.S. FDA has granted orphan-drug designation\" \/>\n<meta name=\"robots\" content=\"index, follow, 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