Shares of European pharmaceutical company Novo Nordisk (NVO) are up 6% on reports that the U.S. Food and Drug Administration (FDA) has accepted the company’s application for a pill version of its Wegovy weight loss medication.
If approved, the pill would be the first oral treatment for weight loss in adults. Currently, Wegovy is administered through an injection. Pill forms of weight loss medicines are viewed by analysts and investors as a major breakthrough that could lead to billions of dollars in profits for the pharmaceutical companies that develop them.
Novo Nordisk’s submission to the FDA for a weight loss pill is based on results from a Phase 3 clinical trial that studied a 25 mg dose of oral medicine given to adults who are obese. The 64-week trial showed positive results that lead the company to believe a pill form of Wegovy is possible.
The FDA’s final decision on a pill version of Wegovy is expected in the fourth quarter of this year. Investors are optimistic that an oral version of the blockbuster drug could lead to greater adoption among consumers and solidify Novo Nordisk’s lead in obesity care and weight management.
However, Novo Nordisk’s main competitor Eli Lilly (LLY) is also developing a weight loss pill that is still in clinical trials. Eli Lilly expects to file for regulatory approval for its obesity pill later this year. Despite Novo Nordisk’s potential advantage in the oral weight loss drug market, its stock has fallen in recent months.
NVO stock has declined 36% in the past six months.