{"id":167364,"date":"2025-11-07T05:33:06","date_gmt":"2025-11-07T05:33:06","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/167364\/"},"modified":"2025-11-07T05:33:06","modified_gmt":"2025-11-07T05:33:06","slug":"us-fda-awards-six-more-fast-track-vouchers-to-speed-drug-reviews","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/167364\/","title":{"rendered":"US FDA awards six more fast-track vouchers to speed drug reviews"},"content":{"rendered":"<p>Nov 6 (Reuters) &#8211; The U.S. Food and Drug Administration said on Thursday it has awarded six more companies, including Eli Lilly and Novo Nordisk, special vouchers that will speed up the review of their medicines, bringing the total number of recipients to 15.<\/p>\n<p>The vouchers went to treatments for cancer, obesity, tuberculosis and sickle cell disease.<\/p>\n<p data-testid=\"promo-box\" class=\"text-module__text__0GDob text-module__dark-grey__UFC18 text-module__regular__qJJtA text-module__small__sph8i body-module__base__o--Cl body-module__small_body__gOmDf article-body-module__promo-box__hVl8h\"> Sign up  <a data-testid=\"Link\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-awards-six-more-fast-track-vouchers-speed-drug-reviews-2025-11-06\/undefined?location=article-paragraph&amp;redirectUrl=%2Fbusiness%2Fhealthcare-pharmaceuticals%2Fus-fda-awards-six-more-fast-track-vouchers-speed-drug-reviews-2025-11-06%2F\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC\" rel=\"nofollow noopener\" target=\"_blank\">here.<\/a><\/p>\n<p>Among the selected products are Novo&#8217;s <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/NOVOb.CO\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(NOVOb.CO), opens new tab<\/a> weight-loss drug Wegovy and Lilly&#8217;s <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/LLY.N\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(LLY.N), opens new tab<\/a> experimental obesity pill orforglipron.The vouchers are part of the Commissioner&#8217;s National Priority Voucher, a pilot program launched in <a data-testid=\"Link\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-issue-new-vouchers-drug-developers-shorten-review-time-2025-06-17\/\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC\" rel=\"nofollow noopener\" target=\"_blank\">June<\/a> to accelerate FDA decisions for drugs that address key public health or national security needs. Companies that receive a voucher can expect a decision within one to two months, compared to the typical 10 to 12 months.The announcement coincided with the Trump administration unveiling <a data-testid=\"Link\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/novo-lilly-shares-rise-trump-obesity-drug-deal-nears-2025-11-06\/\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC\" rel=\"nofollow noopener\" target=\"_blank\">pricing agreements<\/a> with the two drugmakers for their weight-loss treatments. In exchange for lowering prices for Medicare and Medicaid, both companies received priority review vouchers.<\/p>\n<p>Michael Leuchten, an analyst at Jefferies, said the vouchers are &#8220;unlikely to favor Novo.&#8221;<\/p>\n<p>Leuchten added that since approval for Novo&#8217;s oral Wegovy is already anticipated before year-end, &#8220;the benefit of this voucher appears more modest to Novo.&#8221;<\/p>\n<p>Shares of Lilly closed up just over 1%, while U.S.-listed shares of Novo Nordisk fell 4% on Thursday.<\/p>\n<p>The recipients also included Vertex Pharmaceuticals&#8217; <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/VRTX.O\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(VRTX.O), opens new tab<\/a> gene therapy Casgevy for sickle cell disease, GSK&#8217;s <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/GSK.L\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(GSK.L), opens new tab<\/a> dostarlimab for rectal cancer, Johnson &amp; Johnson&#8217;s <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/JNJ.N\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(JNJ.N), opens new tab<\/a> bedaquiline for drug-resistant tuberculosis in young children, and Boehringer Ingelheim&#8217;s zongertinib for a type of lung cancer.<\/p>\n<p>FDA Commissioner Marty Makary said the vouchers are awarded to companies that commit to making their drugs more affordable, manufacturing them in the U.S., or addressing unmet health needs. &#8220;We are pioneering new ways of bringing these cures and meaningful treatments to the market faster,&#8221; he said.<\/p>\n<p>The FDA announced its <a data-testid=\"Link\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-announces-recipients-national-priority-vouchers-2025-10-16\/\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC\" rel=\"nofollow noopener\" target=\"_blank\">first batch<\/a> of nine vouchers in October.<\/p>\n<p>(This story has been corrected to remove the reference to the oral version of Wegovy in paragraph 3)<\/p>\n<p data-testid=\"SignOff\" class=\"text-module__text__0GDob text-module__dark-grey__UFC18 text-module__regular__qJJtA text-module__extra_small__8Buss body-module__full_width__kCIGb body-module__extra_small_body__Bfz20 sign-off-module__text__LQAMP\">Reporting by Kamal Choudhury in Bengaluru; Editing by Alan Barona<\/p>\n<p data-testid=\"Body\" dir=\"ltr\" class=\"text-module__text__0GDob text-module__dark-grey__UFC18 text-module__regular__qJJtA text-module__small__sph8i body-module__base__o--Cl body-module__small_body__gOmDf article-body-module__element__5eCce article-body-module__trust-badge__5mS3f\">Our Standards: <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.thomsonreuters.com\/en\/about-us\/trust-principles.html\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__dark-grey__UFC18 text-module__medium__2Rl30 text-module__small__sph8i link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">The Thomson Reuters Trust Principles., opens new tab<\/a><\/p>\n<p><a href=\"https:\/\/www.reutersagency.com\/en\/licensereuterscontent\/?utm_medium=rcom-article-media&amp;utm_campaign=rcom-rcp-lead\" target=\"_blank\" dir=\"ltr\" class=\"button-module__link__A3sD0 button-module__secondary__70gBu button-module__round__QDFgq button-module__w_auto__Sem-F\" data-testid=\"LicenceContentButton\" rel=\"nofollow noopener\">Purchase Licensing Rights<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Nov 6 (Reuters) &#8211; The U.S. Food and Drug Administration said on Thursday it has awarded six more&hellip;\n","protected":false},"author":2,"featured_media":167365,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[274],"tags":[82519,2786,82703,82499,96154,36586,94443,82517,72110,82500,82795,83800,87219,83400,82702,18,55396,82520,82516,45748,87209,135,87211,19,17,11203,96156,50178,462,96153,96155,96157,82524,83000,2765,88228,88229,83810,82510,82964,96152,83363,83401,83801,82534,88232,82533,107,82518],"class_list":{"0":"post-167364","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-amers","9":"tag-asia","10":"tag-asxpac","11":"tag-bact","12":"tag-biodrg","13":"tag-biz","14":"tag-caribn","15":"tag-ceeu","16":"tag-ch","17":"tag-cmpny","18":"tag-cprod","19":"tag-cwp","20":"tag-destoushem","21":"tag-dk","22":"tag-easia","23":"tag-eire","24":"tag-emea","25":"tag-europ","26":"tag-gb","27":"tag-gen","28":"tag-hea","29":"tag-health","30":"tag-heca","31":"tag-ie","32":"tag-ireland","33":"tag-jp","34":"tag-ky","35":"tag-latam","36":"tag-medication","37":"tag-medreg","38":"tag-mrch","39":"tag-mrch1","40":"tag-namer","41":"tag-nord","42":"tag-phar","43":"tag-phar1","44":"tag-phmr","45":"tag-privt","46":"tag-publ","47":"tag-regs","48":"tag-rhpiregulatory","49":"tag-rsbiregulatory-oversight","50":"tag-scandv","51":"tag-secur","52":"tag-topcmb","53":"tag-topicpharma-healthcare-policy-regulation","54":"tag-topnws","55":"tag-us","56":"tag-weu"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ie\/115506787306866648","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/167364","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=167364"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/167364\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/167365"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=167364"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=167364"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=167364"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}