Eli Lilly<\/a> said on \u2060Thursday its newly approved obesity pill was not inferior to a widely used long-acting insulin at \u200blowering the risk of \u200bmajor heart problems in \u200bpatients with type 2 diabetes and obesity.<\/p>\nThe U.S. Food and Drug Administration approved the pill, Foundayo, for weight loss earlier this month, intensifying Lilly’s competition with Danish \u2060rival \u200cNovo Nordisk, whose oral Wegovy has been on \u2060the market since January.<\/p>\n
The late-stage study data also adds to the obesity drug’s potential in diabetes, boosting Lilly’s position in the multi-billion-dollar market, where drugmakers are racing to develop more convenient \u200coral options as an alternative to injectables.<\/p>\n
Lilly said it will seek U.S. approval of Foundayo for type 2 diabetes under the Commissioner’s \u200bNational Priority Review Voucher, which aims to speed up FDA decisions on drugs deemed critical to public health or national security.<\/p>\n
The company will submit an application by the end of the second quarter, \u2060it added.<\/p>\n
The trial of 2,700 patients, who were at increased cardiovascular risk, showed Foundayo lowered \u200cthe risk of heart attack, stroke or cardiovascular \u200cdeath by 16%, when compared with those on insulin glargine. The drug lowered the risk of death from any cause by 57%.<\/p>\n
Foundayo also helped improve patients’ A1C levels – \u2060which measure average blood sugar levels over the past few months – and body \u2060weight at 52 weeks.<\/p>\n
Insulin glargine, sold under brands such \u2060as Sanofi’s Lantus and Lilly’s Basaglar, is a long-acting, man-made insulin used to control blood sugar in type 1 and type \u200b2 diabetes patients.<\/p>\n
The FDA had asked \u200cLilly for additional post-marketing studies and more data on liver injury for Foundayo.<\/p>\n
Lilly said the trial also included an analysis of potential liver injury and found no liver safety concerns, consistent with earlier studies.<\/p>\n
This data should allay fears that Foundayo faces \u200bunique liver safety risks versus competitors \u200clike oral Wegovy, said RBC Capital Markets analyst Trung Huynh.<\/p>\n
Choose CNBC as your preferred source on Google and never miss a moment from the most trusted name in business news.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Eli Lilly Foundayo GLP-1 weight loss pill. Courtesy: Eli Lilly Eli Lilly said on \u2060Thursday its newly approved…\n","protected":false},"author":2,"featured_media":587973,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59],"tags":[2602,28,122,16161,97,252,2601,253],"class_list":{"0":"post-587972","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health-care","8":"tag-biotech-and-pharmaceuticals","9":"tag-business","10":"tag-business-news","11":"tag-eli-lilly-and-co","12":"tag-health","13":"tag-health-care","14":"tag-health-care-industry","15":"tag-healthcare"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/587972","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=587972"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/587972\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/587973"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=587972"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=587972"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=587972"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}