{"id":129225,"date":"2025-11-12T13:03:29","date_gmt":"2025-11-12T13:03:29","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/129225\/"},"modified":"2025-11-12T13:03:29","modified_gmt":"2025-11-12T13:03:29","slug":"fda-adds-6-more-meds-to-pilot-program-for-speedy-review-of-drugs-in-the-national-interest","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/129225\/","title":{"rendered":"FDA Adds 6 More Meds to Pilot Program for Speedy Review of Drugs in the National Interest"},"content":{"rendered":"

Two obesity drugs are among the six new medications that could get faster FDA review<\/a> under a new pilot program open to products addressing certain national health priorities.<\/p>\n

Rare and infectious diseases as well as cancer are the other therapeutic areas covered by the new batch of voucher recipients. The vouchers announced Thursday come three weeks after the FDA unveiled the first nine drugs selected for this Commissioner\u2019s National Priority Voucher (CNPV) program<\/a>. Eligible products must meet criteria such as improving affordability or increasing domestic manufacturing. Another consideration is addressing an unmet public health need.<\/p>\n

The obesity drugs awarded vouchers are Novo Nordisk\u2019s injectable GLP-1 drug Wegovy, and Eli Lilly\u2019s oral GLP-1 drug orforglipron. While Wegovy is already approved for obesity, Novo is studying applications of the drug in related indications. In August, Wegovy expanded its approval to include the fatty liver disease MASH<\/a>. Lilly\u2019s orforglipron is not yet approved, but could offer patients a more convenient oral alternative to GLP-1 injections. In Lilly\u2019s report<\/a> of third quarter 2025 financial results, the company said it plans an FDA submission for orforglipron by the end of the year.<\/p>\n

Two cancer drugs are receiving vouchers. The first is Boehringer Ingelheim\u2019s zongertinib, brand name Hernexeos. In August, the FDA awarded Hernexeos accelerated approval as a second-line treatment for advanced cases of non-small cell lung cancer<\/a> that expresses the cancer protein HER2. A Phase 3 test is evaluating the Boehringer pill in this indication as a first-line treatment alongside the Merck checkpoint inhibitor Keytruda. Preliminary data are expected late next year.<\/p>\n

The GSK checkpoint inhibitor dostarlimab, brand name Jemperli, is the other cancer drug awarded a voucher. Initially approved in 2021 for treating endometrial cancer with the dMMR genetic signature<\/a>, Jemperli has since expanded its approved uses to all solid tumors with that signature<\/a>. The voucher covers potential use of the product in rectal cancer, where it could provide a drug alternative to surgery<\/a>.<\/p>\n

Vertex Pharmaceuticals received a voucher for Casgevy. The 2023 FDA approval of this gene therapy<\/a> covered sickle cell disease patients age 12 and older. A clinical trial is ongoing that could support expanding use of this product to patients ages 5 to 11.<\/p>\n

Rounding out the list is Johnson & Johnson antibiotic bedaquiline, brand name Sirturo, a treatment for tuberculosis in adults and children age 5 and older. Last year, the FDA converted<\/a> the drug\u2019s accelerated approval to a traditional one. The voucher covers applications of Sirturo to drug-resistant tuberculosis in young children.<\/p>\n

The products awarded vouchers were selected from external company applications and internal nominations from the FDA\u2019s 27 review divisions<\/a> across therapeutic areas. While standard drug review can take ten months to a year, the FDA says a national priority voucher could lead to a regulatory decision \u201cwithin months.\u201d Faster decisions will come from a one-day team-based review that brings together a multidisciplinary selection of physicians and scientists from across the agency.<\/p>\n

Commissioner Marty Makary unveiled the new priority review vouch program this past June<\/a>. The FDA notes the agency is permitted to test innovative regulatory approaches under three federal laws: the Food, Drug, and Cosmetics Act; the 21st Century Cures Act; and the Food and Drug Administration Safety and Innovation Act.<\/p>\n

\u201cWe are pioneering new ways of bringing these cures and meaningful treatments to the market faster,\u201d Makary said in a prepared statement.<\/p>\n

Photo by FDA<\/p>\n","protected":false},"excerpt":{"rendered":"Two obesity drugs are among the six new medications that could get faster FDA review under a new…\n","protected":false},"author":2,"featured_media":129226,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":{"0":"post-129225","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-il","10":"tag-israel","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/129225","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=129225"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/129225\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/129226"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=129225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=129225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=129225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}