{"id":89739,"date":"2026-05-22T15:25:11","date_gmt":"2026-05-22T15:25:11","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/89739\/"},"modified":"2026-05-22T15:25:11","modified_gmt":"2026-05-22T15:25:11","slug":"novo-nordisks-wegovy-pill-wins-key-eu-backing-nvo-sec-filing","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/89739\/","title":{"rendered":"Novo Nordisk\u2019s Wegovy pill wins key EU backing | 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\">May 22, 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\/05\/1779463510_602_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\/05\/1779463511_755_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: 0pt 5pt 0pt 1.15pt\">Wegovy\u00ae pill (oral<br \/>\nsemaglutide) recommended by CHMP for approval in the EU as the first oral GLP-1 representing<br \/>\nthe most efficacious oral obesity treatment in its class<\/p>\n<p style=\"margin: 0pt 5pt 0pt 1.15pt; font-size: 10pt\">\u00a0<\/p>\n<p>\u00b7With<br \/>\n                                            a mean weight loss of 16.6%1, Wegovy\u00ae pill demonstrates best-in-class weight-loss<br \/>\n                                            efficacy and is the first oral GLP-1 treatment recommended by CHMP for weight management<br \/>\n                                            in the EU.<\/p>\n<p>\u00b7CHMP recommends Wegovy\u00ae pill for approval to reduce excess body weight and maintain<br \/>\nlong-term weight reduction. The recommendation also includes data from SELECT which demonstrates that Wegovy\u00ae reduces the risk<br \/>\nof major adverse cardiovascular events (MACE)*, in the label.<\/p>\n<p>\u00b7Wegovy\u00ae pill is the only oral GLP-1 treatment with no drug-drug restrictions in the label.<\/p>\n<p>\u00b7Novo Nordisk plans to launch Wegovy\u00ae pill in select markets<br \/>\noutside the US in the second half of 2026.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">Bagsv\u00e6rd, Denmark, 22 May 2026 \u2013<br \/>\nNovo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency<br \/>\n(EMA) has adopted a positive opinion, recommending marketing authorisation of Wegovy\u00ae<br \/>\npill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain long-term weight reduction.<br \/>\nThe positive opinion also includes SELECT data in the label, demonstrating that Wegovy\u00ae<br \/>\nreduces the risk of major adverse cardiovascular events (MACE)*.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">Wegovy\u00ae pill is the first oral glucagon-like peptide-1<br \/>\n(GLP-1) receptor agonist therapy recommended for approval by CHMP for weight management in the EU.<br \/>\nThe recommendation is based on the OASIS trial programme and the SELECT2 trial.<br \/>\nIn the OASIS 4 trial, oral semaglutide 25 mg taken once daily demonstrated 16.6% mean weight loss when treatment was adhered to in adult<br \/>\nparticipants with obesity or overweight with one or more comorbidities1. The weight loss<br \/>\nachieved with Wegovy\u00ae pill is similar to that of injectable Wegovy\u00ae<br \/>\n2.4 mg. Furthermore, one in three people experienced 20% or greater weight loss in the OASIS 4 trial1.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">*Includes cardiovascular death, non-fatal heart<br \/>\nattack (myocardial infarction) or non-fatal stroke.<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">1Based on the trial product estimand from OASIS<br \/>\n4 trial, ie treatment effect if all people adhered to treatment.<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">2Supported with data from the STEP trial programme<br \/>\nand the PIONEER PLUS trial.<\/p>\n<p>\u00a0<\/p>\n<p style=\"font: 10pt Times New Roman, Times, Serif; margin: 0pt 6.15pt 0pt 0; text-align: right\">Page 2 of 3<\/p>\n<p style=\"font: 10pt Times New Roman, Times, Serif; margin: 0pt\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">The well-known safety and tolerability profile<br \/>\nof semaglutide was reaffirmed with Wegovy\u00ae pill in the OASIS 4 trial, which was comparable<br \/>\nto previous semaglutide trials for weight management. Semaglutide is supported by more than 50 million patient-years of real-world safety<br \/>\ndata, and notably, the Wegovy\u00ae pill label includes no drug\u2013drug restrictions with concomitant<br \/>\nmedications.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">\u201cWe are encouraged by CHMP\u2019s positive<br \/>\nopinion for Wegovy\u00ae pill, bringing the most efficacious oral GLP-1 in its class one step closer<br \/>\nto becoming the first approved oral treatment in its class for weight management in the EU\u201d, said Mike Doustdar, president<br \/>\nand CEO of Novo Nordisk. \u201cThe demand for effective and convenient obesity treatment is already evident in the U.S., where more than<br \/>\n1 million Americans began using Wegovy\u00ae pill within the first four months following launch. We<br \/>\nlook forward to bringing this innovative medicine to the first markets outside the US in the second half of 2026.\u201d<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">About the OASIS trial programme<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">OASIS was a phase 3 clinical development programme with once-daily oral semaglutide<br \/>\n25 mg and 50 mg in obesity. The global clinical phase 3 programme consisted of four trials, enrolling<br \/>\napproximately 1,300 adults with obesity or overweight with one or more comorbidities. OASIS<br \/>\n4 was a 64-week efficacy and safety phase 3b trial of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity<br \/>\nor overweight with one or more comorbidities.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">About Wegovy\u00ae<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">Once-weekly Wegovy\u00ae injection (2.4 mg and<br \/>\n7.2 mg) is approved by the FDA, EMA and other regulatory authorities worldwide. Wegovy\u00ae<br \/>\nis approved as once-daily Wegovy\u00ae pill (semaglutide 25 mg) by the FDA. Wegovy\u00ae<br \/>\npill is currently pending marketing approval from the EMA and other regulatory authorities.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">Wegovy\u00ae<br \/>\nis indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and in the<br \/>\npresence of at least one weight-related comorbid condition, and approved by the FDA to reduce the<br \/>\nrisk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either<br \/>\nobesity or overweight. Furthermore, Wegovy\u00ae injection is indicated to reduce excess body weight<br \/>\nand maintain long-term weight reduction in paediatric patients aged 12 years and older. It is approved by the FDA for the treatment of<br \/>\nMASH in adults with moderate to advanced liver scarring (fibrosis), but not in those with cirrhosis of the liver.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">About Novo Nordisk<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered<br \/>\nin Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering<br \/>\nscientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about<br \/>\n67,900 people in 80 countries and markets its products in around 170 countries. Novo Nordisk&#8217;s B shares are listed on Nasdaq Copenhagen<br \/>\n(Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram,<br \/>\nX, LinkedIn and YouTube.<\/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 6.15pt 0pt 0; text-align: right\">Page 3 of<br \/>\n3<\/p>\n<p style=\"font: 10pt Times New Roman, Times, Serif; margin: 0pt\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">Publication of inside information pursuant to<br \/>\nMarket Abuse Regulation, Article 17.<\/p>\n<p style=\"font-size: 10pt; margin: 0pt 0\">\u00a0<\/p>\n<p style=\"margin: 0pt; font-size: 10pt\">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 \/>\n  Liz Skrbkova (US)<\/p>\n<p>  +45 3079 9289<br \/>\n  +1 609 917 0632<\/p>\n<p>  globalmedia@novonordisk.com<br \/>\n  usmediarelations@novonordisk.com<\/p>\n<p>  \u00a0<br \/>\n  \u00a0<\/p>\n<p>  Novo Nordisk Investors:<br \/>\n  \u00a0<\/p>\n<p>  Michael Novod<br \/>\n  Jacob Martin Wiborg Rode<\/p>\n<p>  +45 3075 6050<br \/>\n  +45 3075 5956<\/p>\n<p>  nvno@novonordisk.com<br \/>\n  jrde@novonordisk.com<\/p>\n<p>  \u00a0<br \/>\n  \u00a0<\/p>\n<p>  Sina Meyer<br \/>\n  Christoffer Sho Togo Tullin<\/p>\n<p>  +45 3079 6656<br \/>\n  +45 3079 1471<\/p>\n<p>  azey@novonordisk.com<br \/>\n  cftu@novonordisk.com<\/p>\n<p>  \u00a0<br \/>\n  \u00a0<\/p>\n<p>  Alex Bruce<br \/>\n  Mads Berner Bruun<\/p>\n<p>  +45 3444 2613<br \/>\n  +45 3075 2936<\/p>\n<p>  axeu@novonordisk.com<br \/>\n  mbbz@novonordisk.com<\/p>\n<p>  \u00a0<br \/>\n  \u00a0<\/p>\n<p>  Frederik Taylor Pitter<br \/>\n  \u00a0<\/p>\n<p>  +1 609 613 0568<br \/>\n  \u00a0<\/p>\n<p>  fptr@novonordisk.com<br \/>\n  \u00a0<\/p>\n<p style=\"margin: 0pt 0; font-size: 10pt\">\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<br \/>\n                                            announcement No 33 \/ 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: May 22, 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","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":89740,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[271],"tags":[47444,47443,32083,47442,3335,272,3859,47445,16370,785],"class_list":["post-89739","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novo-nordisk","tag-cardiovascular-risk-reduction","tag-chmp-opinion","tag-ema-approval","tag-eu-obesity-treatment","tag-glp-1","tag-novo-nordisk","tag-nvo","tag-oasis-4-trial","tag-oral-semaglutide","tag-wegovy-pill"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@dk\/116618928257504240","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/89739","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=89739"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/89739\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/89740"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=89739"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=89739"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=89739"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}