{"id":15048,"date":"2019-09-09T18:18:54","date_gmt":"2019-09-09T16:18:54","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=15048"},"modified":"2019-09-10T18:25:04","modified_gmt":"2019-09-10T16:25:04","slug":"proqr-receives-fast-track-designation-from-fda","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/proqr-receives-fast-track-designation-from-fda\/","title":{"rendered":"ProQR Receives Fast Track Designation from FDA"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">ProQR Therapeutics, a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced that it received Fast Track designation from the\u00a0Food and Drug Administration\u00a0(FDA) for QR-1123.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">QR-1123 is a\nfirst-in-class investigational antisense oligonucleotide designed to address\nthe underlying cause of vision loss associated with autosomal dominant\nretinitis pigmentosa (adRP) due to the P23H mutation in the rhodopsin (<em>RHO<\/em>) gene.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Fast Track\ndesignation is granted by&nbsp;the FDA&nbsp;to drugs in development for serious\nconditions with the potential to fulfill an unmet medical need. It was\nestablished with the intention to bring promising drugs to patients sooner by\nfacilitating development with more frequent&nbsp;FDA&nbsp;interactions and\nexpediting the review process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cWe are very pleased to receive Fast Track designation by the\u00a0FDA\u00a0for QR-1123. There are no current treatment options available for patients to improve vision or prevent vision loss due to adRP. Further, this designation emphasizes the high unmet need in this disease,\u201d said\u00a0Daniel de Boer, Chief Executive Officer of ProQR. \u201cWe look forward to beginning enrollment in the Phase 1\/2 (Aurora) clinical trial for QR-1123 in the coming months.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Source: <a href=\"https:\/\/ir.proqr.com\/news-releases\/news-release-details\/proqr-receives-fast-track-designation-fda-qr-1123-autosomal\">ProQR<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ProQR Therapeutics, a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced that it received Fast Track designation from the\u00a0Food and Drug Administration\u00a0(FDA) for QR-1123. QR-1123 is a first-in-class investigational antisense oligonucleotide designed to address the underlying cause of vision loss associated [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[43],"tags":[],"class_list":["post-15048","post","type-post","status-publish","format-standard","hentry","category-innovatieklimaat"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ProQR Receives Fast Track Designation from FDA - hollandbio<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hollandbio.nl\/en\/nieuws\/proqr-receives-fast-track-designation-from-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ProQR Receives Fast Track Designation from FDA - hollandbio\" \/>\n<meta property=\"og:description\" content=\"ProQR Therapeutics, a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced that it received Fast Track designation from the\u00a0Food and Drug Administration\u00a0(FDA) for QR-1123. 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