{"id":104445,"date":"2026-06-10T10:17:38","date_gmt":"2026-06-10T10:17:38","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/104445\/"},"modified":"2026-06-10T10:17:38","modified_gmt":"2026-06-10T10:17:38","slug":"ema-backs-novos-wegovy-pill-first-oral-weight-loss-drug-for-europe","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/104445\/","title":{"rendered":"EMA backs Novo’s Wegovy pill, first oral weight-loss drug for Europe"},"content":{"rendered":"

European Commission to review recommendation for final approvalNovo plans to launch the pill in select markets in second halfWegovy pill has shown 16.6% average weight loss in late-stage studyMay 22 (Reuters) – The \u200cEuropean Medicines Agency recommended approval of Novo Nordisk’s (NOVOb.CO), opens new tab<\/a> pill Wegovy, the regulator said on Friday, clearing the way for it to become the first oral weight-loss drug in Europe, ahead of U.S. rival Eli Lilly (LLY.N), opens new tab<\/a>.<\/p>\n

The recommendation comes as competition between \u200bNovo and Lilly intensifies, with both companies seeking to grow their share of the booming \u200bobesity drug market, which analysts expect to reach over a $100 billion annually in \u2060the next decade, by expanding into oral treatments.<\/p>\n

Sign up here.<\/a><\/p>\n

Novo launched the oral drug in the United States earlier this year after \u200bwinning FDA approval<\/a>, giving it an early start. Lilly’s weight-loss pill, Foundayo, was launched in April following its \u200bU.S. approval.<\/a><\/p>\n

The pill, which Novo plans to launch in some markets outside the U.S. in the second half of 2026, contains semaglutide, the same active ingredient used in its blockbuster injectable drugs Wegovy for weight loss and Ozempic for diabetes.<\/p>\n

The \u200bEMA said tablets may be more convenient for some patients. A 25 milligram dose of the pill \u200bhelped patients lose an average 16.6% of their body weight, compared with 2.7% for those on placebo over 64 \u200cweeks in \u2060a late-stage study.<\/p>\n

Unlike Lilly’s drug, the Wegovy pill must be taken while fasting and without other medicines, though this is not a major barrier once patients are instructed, said Tricia Tan, professor of metabolic medicine and endocrinology at Imperial College London, adding that they might struggle to remember to take it daily. \u200bLilly’s drug is still \u200bunder review by the \u2060EMA.<\/p>\n

\"U.S.U.S. prescriptions for Novo Nordisk’s oral WegovyEarly U.S. prescription data for both oral drugs has supported the view that these can drive market expansion<\/a> by bringing in new patients.<\/p>\n

Dr. Anita Phung, research physician \u200band medical monitor at Lindus Health said that regulatory success does not \u200bguarantee wide patient \u2060access, noting that reimbursement policies differ across Europe and injectable Wegovy is often limited to specialist services rather than primary care.<\/p>\n

The recommendations will now be reviewed by the European Commission, which will give final marketing authorization. \u2060The agency \u200balso backed approval for a 7.2 mg dose Wegovy in \u200ba single pen, which is expected to be launched in the third quarter.<\/p>\n

Reporting by Kunal \u200bDas and Puyaan Singh in Bengaluru and Bhanvi Satija in London; Editing by Tasim Zahid and Shailesh Kuber<\/p>\n

Our Standards: The Thomson Reuters Trust Principles., opens new tab<\/a><\/p>\n

Purchase Licensing Rights<\/a>\"Bhanvi<\/a><\/p>\n

Bhanvi is a London-based reporter covering European pharmaceutical companies and the healthcare industry. She previously covered U.S. health and pharma firms, with a focus on the new weight loss drugs that are transforming the obesity treatment space. Her coverage includes a trend piece on the underuse of their weight-loss drugs among men, increased interest in therapies being developed for preservation of lean mass, and a scoop on gene therapy maker Sarepta defying an FDA order to stop shipping its muscular dystrophy treatment.<\/p>\n","protected":false},"excerpt":{"rendered":"European Commission to review recommendation for final approvalNovo plans to launch the pill in select markets in second…\n","protected":false},"author":2,"featured_media":104446,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[271],"tags":[10285,24616,10229,3161,53270,10255,53271,53269,10253,53268,10247,30365,10249,327,10246,18543,10250,10274,24613,53259,53260,53261,18540,5693,53262,24614,10267,10286,18549,10248,272,53255,53263,53264,53265,53266,10279,10260,24593,10281,10282,53267,53258,53257,10245,53272,10265,53256,10264,652,10244],"class_list":["post-104445","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novo-nordisk","tag-amers","tag-anlins","tag-bact","tag-biz","tag-blux","tag-cmpny","tag-cprod","tag-destohlt","tag-destoukbsm","tag-destoushem","tag-dk","tag-eeu","tag-emea","tag-eu","tag-europ","tag-ezc","tag-fin","tag-gen","tag-graphc","tag-hea","tag-heca","tag-humdis","tag-intag","tag-legal","tag-medreg","tag-mtgfx","tag-mtpix","tag-namer","tag-nl","tag-nord","tag-novo-nordisk","tag-nrlpaohlt","tag-obesit","tag-phar","tag-phar1","tag-phmr","tag-pol","tag-privt","tag-publ","tag-pxp","tag-regs","tag-reuters-legal","tag-rhpiregulatory","tag-rsbiregulatory-oversight","tag-scandv","tag-sci","tag-topcmb","tag-topicpharma-healthcare-policy-regulation","tag-topnws","tag-us","tag-weu"],"share_on_mastodon":{"url":"","error":"Validation failed: Text character limit of 500 exceeded"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/104445","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=104445"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/104445\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/104446"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=104445"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=104445"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=104445"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}