By Kelly Cloonan
Novo Nordisk said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on the market.
The Bagsvaerd, Denmark, company said Friday that if the application is approved, Wegovy would become the first oral formulation of a GLP-1 drug for chronic weight management.
The FDA's deadline to decide on the application will be in the fourth quarter, the company said.
The application is based on results from a phase 3 randomized, controlled trial evaluating the efficacy and safety of the drug over 64 weeks, the company said.
Last month, Eli Lilly said its oral obesity and type 2 diabetes treatment, called orforglipron, met its goals in the first of several studies expected this year. Companies such as Pfizer, Structure Therapeutics and Viking Therapeutics are also developing their own weight-loss pills.
Currently, all approved GLP-1s for weight loss are given by injection.
"We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations," said Anna Windle, senior vice president of clinical development, medical and regulatory affairs at Novo Nordisk.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
May 02, 2025 15:33 ET (19:33 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。