Danish drugmaker Novo Nordisk has received the world's first approval to sell an oral glucagon-like peptide-1 (GLP-1) obesity treatment. Wegovy in pill form, rather than an injection, has been recognized for both weight loss and reducing cardiovascular risk, widening options for obesity treatment.
Novo Nordisk said on the 22nd (local time) that it received approval from the U.S. Food and Drug Administration (FDA) for the oral obesity drug "Wegovy pill (Wegovy® pill)" to manage weight and reduce the risk of major adverse cardiovascular events in patients with obesity or overweight. The Wegovy pill is set to launch in the U.S. market in early January next year.
The approved Wegovy pill is a once-daily 25 mg semaglutide formulation, the world's first oral GLP-1 receptor agonist for treating obesity. It uses the same ingredient as the existing injectable Wegovy (2.4 mg) while improving convenience of use. It can be chosen relatively easily by patients averse to injections, and it does not require refrigerated storage or a cold chain, which is considered another advantage.
The safety and efficacy of oral Wegovy were confirmed in a phase 3 clinical trial. Adults with obesity or overweight who took the Wegovy pill for 64 weeks showed an average 16.6% weight loss, similar to the injectable Wegovy. One in three participants lost 20% or more of their body weight.
In addition to weight loss, improvements in cardiovascular disease were also confirmed. The FDA determined that the Wegovy pill helps reduce the risk of major adverse cardiovascular events such as heart attack and stroke. Its safety profile was assessed to be largely consistent with existing semaglutide-class drugs.
Novo Nordisk plans to launch at an affordable price to secure an early foothold in the market. In early January next year, it will first supply the 1.5 mg starting dose of the Wegovy pill. The discounted price for self-pay patients is $149 per month (220,967 won), the lowest among Novo's GLP-1 obesity treatments.
Novo Nordisk submitted marketing applications for the Wegovy pill to several countries, including the European Medicines Agency (EMA), in the second half of last year. Following U.S. approval, competition in oral GLP-1s is expected to intensify in the global obesity treatment market.
Mike Doustdar, CEO of Novo Nordisk, said, "With this approval, patients can choose a convenient pill option with effects equivalent to an injection," and added, "No currently marketed oral GLP-1 therapy has shown the same weight loss effect as the Wegovy pill."