{"id":50778,"date":"2026-03-28T21:05:22","date_gmt":"2026-03-28T21:05:22","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/50778\/"},"modified":"2026-03-28T21:05:22","modified_gmt":"2026-03-28T21:05:22","slug":"novo-nordisk-wins-fda-approval-for-awiqli-insulin-nvo-sec-filing","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/50778\/","title":{"rendered":"Novo Nordisk wins FDA approval for Awiqli insulin | NVO SEC Filing"},"content":{"rendered":"<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">UNITED STATES<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">SECURITIES AND EXCHANGE COMMISSION<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">Washington, D.C. 20549<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">________________<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 18pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">FORM 6-K<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">________________<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">REPORT OF FOREIGN PRIVATE ISSUER<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">Pursuant to Rule 13a-16 or 15d-16<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">of the Securities Exchange Act of 1934<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">March 27, 2026<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">________________<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 18pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">NOVO NORDISK A\/S<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">\u00a0(Exact name<br \/>\nof Registrant as specified in its charter)<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">Novo All\u00e9 1<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">DK- 2880, Bagsvaerd<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">Denmark<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin-top: 0pt; margin-bottom: 0pt\">(Address of principal executive offices)<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin: 0pt 0\">________________<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0; text-indent: 0.5in\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Indicate by check mark whether the registrant files or will file annual reports under<br \/>\ncover of Form 20-F or Form 40-F<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0; text-indent: 0.5in\">\u00a0<\/p>\n<p>    Form 20-F \u2612\u00a0\u00a0\u00a0\u00a0\u00a0<br \/>\n    \u00a0\u00a0\u00a0\u00a0\u00a0Form 40-F \u2610<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0; text-indent: 0.5in\">\u00a0\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: left\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: right\"><img decoding=\"async\" src=\"https:\/\/www.europesays.com\/dk\/wp-content\/uploads\/2026\/03\/1774731921_665_logo.jpg\" alt=\"\" style=\"height: 70px; width: 99px\"\/>\u00a0<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: left\"><img decoding=\"async\" src=\"https:\/\/www.europesays.com\/dk\/wp-content\/uploads\/2026\/03\/ca.jpg\" alt=\"\" style=\"height: 60px; width: 289px\"\/>\u00a0<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: left\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: left\">\u00a0<\/p>\n<p style=\"margin: 0pt 0; font-size: 16pt\">Novo Nordisk A\/S: Awiqli\u00ae approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p>\u2022Awiqli\u00ae\u00a0(insulin icodec-abae) injection is the first-ever once-weekly basal insulin approved by the FDA<\/p>\n<p>\u2022Awiqli\u00ae\u00a0offers adults with type 2 diabetes an alternative to daily basal insulin injections, reducing these injections from seven to one per week<\/p>\n<p>\u2022Novo Nordisk expects to launch Awiqli\u00ae\u00a0nationwide in the US in the second half of 2026.<\/p>\n<p style=\"margin-top: 0; margin-bottom: 0\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Bagsv\u00e6rd, Denmark, 27 March 2026\u00a0\u2013 Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli\u00ae\u00a0(insulin icodec-abae) injection 700 units\/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes. The approval offers the only once-weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">The approval is based on results from the ONWARDS phase 3a programme in type-2-diabetes for once-weekly Awiqli\u00ae\u00a0injection, which comprises four randomised, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and\/or GLP-1 receptor agonists. The clinical programme evaluated once-weekly Awiqli\u00ae\u00a0vs daily basal insulin and demonstrated efficacy in the primary endpoint of HbA1c\u00a0reduction across the ONWARDS pivotal clinical trial programme in adults with type 2 diabetes. Across ONWARDS trials, the safety profile of Awiqli\u00ae\u00a0was overall consistent with the daily basal insulin class.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u201cThe Awiqli\u00ae\u00a0approval reflects Novo Nordisk\u2019s ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes. As the first FDA-approved, once-weekly basal insulin for adults with type 2 diabetes, it offers an important new treatment option. At a time when parts of the industry are stepping back from insulin, we are reaffirming our commitment &#8211; continuing to invest in innovation, access, and supply for the millions of patients who rely on insulin every day,\u201d said Mike Doustdar, president and CEO of Novo Nordisk.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Novo Nordisk expects to launch Awiqli\u00ae\u00a0in the FlexTouch\u00ae\u00a0device in the US in the second half of 2026. Awiqli\u00ae\u00a0is now approved in the US, EU, and 13 additional countries, with market-specific indications for diabetes.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">\u00a0<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">Novo Nordisk A\/S<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">Investor Relations<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">Novo All\u00e9 1<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">2880 Bagsv\u00e6rd<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">Denmark<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">Telephone:<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">+45 4444 8888<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">www.novonordisk.com<br \/>CVR no: 24 25 67 90<\/p>\n<p>\u00a0\u00a0\u00a0Company announcement No 22\/ 2026<\/p>\n<p style=\"margin-top: 0; margin-bottom: 0\">\u00a0<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">About Awiqli\u00ae<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">\u00a0<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">Awiqli\u00ae\u00a0(insulin icodec-abae) injection 700 units\/mL is a prescription medicine and is the first and only FDA-approved once-weekly basal insulin indicated as an adjunct to diet and exercise for adults with type 2 diabetes. Awiqli\u00ae\u00a0is designed as an alternative to daily basal insulin, and its approval is supported by the ONWARDS clinical programme, which evaluated its efficacy and safety across diverse adult populations living with type 2 diabetes. Awiqli\u00ae\u00a0is administered once weekly on the same day each week using the Awiqli\u00ae\u00a0FlexTouch\u00ae\u00a0device.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">About Novo Nordisk<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">\u00a0<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk&#8217;s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit\u00a0novonordisk.com,\u00a0Facebook,\u00a0Instagram,\u00a0X,\u00a0LinkedIn\u00a0and\u00a0YouTube.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Publication of inside information pursuant to Market Abuse Regulation, Article 17.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Contacts for further information<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p>    Novo Nordisk Media:<br \/>\n    \u00a0<\/p>\n<p>    Ambre James-Brown<br \/>+45 3079 9289<br \/>globalmedia@novonordisk.com<br \/>\n    Liz Skrbkova (US)<br \/>+1 609 917 0632<br \/>lzsk@novonordisk.com<\/p>\n<p>    Novo Nordisk Investors:<br \/>\n    \u00a0<\/p>\n<p>    Michael Novod<br \/>+45 3075 6050<br \/>nvno@novonordisk.com<br \/>\n    Jacob Martin Wiborg Rode<br \/>+45 3075 5956<br \/>jrde@novonordisk.com<\/p>\n<p>    Sina Meyer<br \/>+45 3079 6656<br \/>azey@novonordisk.com<br \/>\n    Max Ung<br \/>+45 3077 6414<br \/>mxun@novonordisk.com<\/p>\n<p>    Christoffer Sho Togo Tullin<br \/>+45 3079 1471<br \/>cftu@novonordisk.com<br \/>\n    Alex Bruce<br \/>+45 3444 2613<br \/>axeu@novonordisk.com<\/p>\n<p>    Frederik Taylor Pitter<br \/>+1 609 613 0568<br \/>fptr@novonordisk.com<br \/>\n    \u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"font: 10pt Times New Roman, Times, Serif; margin: 0pt\">\u00a0<\/p>\n<p style=\"font: 10pt Times New Roman, Times, Serif; margin: 0pt\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Novo Nordisk A\/S<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Investor Relations<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Novo All\u00e9 1<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">2880 Bagsv\u00e6rd<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Denmark<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Telephone:<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">+45 4444 8888<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">www.novonordisk.com<br \/>CVR no: 24 25 67 90<\/p>\n<p>\u00a0\u00a0\u00a0Company announcement No 22\/ 2026<\/p>\n<p style=\"margin-top: 0; margin-bottom: 0\">\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin: 0pt 0\">SIGNATURES<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0; text-indent: 0.5in\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0; text-indent: 0.5in\">\u00a0<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has<br \/>\nduly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0; text-indent: 0.5in\">\u00a0<\/p>\n<p>    Date: March 27, 2026<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0; text-indent: 0.5in\">\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin: 0pt 0\">NOVO NORDISK A\/S<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0; text-indent: 0.5in\">\u00a0<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin: 0pt 0\">Maziar Mike Doustdar<\/p>\n<p style=\"font-size: 10pt; text-align: center; margin: 0pt 0\">Chief Executive Officer<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n<p style=\"margin: 0\">\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"\u00a0 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 \u00a0 ________________ \u00a0 FORM 6-K ________________ \u00a0 REPORT&hellip;\n","protected":false},"author":2,"featured_media":50779,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[271],"tags":[27733,18205,7734,272,3859,28241,28242,2142],"class_list":["post-50778","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novo-nordisk","tag-awiqli","tag-diabetes-treatment","tag-fda-approval","tag-novo-nordisk","tag-nvo","tag-once-weekly-basal-insulin","tag-onwards-phase-3a","tag-type-2-diabetes"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@dk\/116308837972128641","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/50778","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/comments?post=50778"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/50778\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/50779"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=50778"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=50778"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=50778"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}