Novo Nordisk’s obesity pill received a positive opinion from the European Medicines Agency (EMA) on Friday, giving it a head start over Eli Lilly’s competing oral treatment, which is still awaiting European approval.
The European Commission is expected to make the final decision on the drug’s authorization in the coming weeks. The Commission almost always follows EMA recommendations.
The pill contains 25 mg of semaglutide and, according to the manufacturer, delivers the same weight loss as the injectable forms that have been on the market for years.
Novo Nordisk already offers a semaglutide pill in both Europe and the United States, but that version contains a much lower dose and has only been approved for the treatment of type 2 diabetes.
The new pill is intended exclusively for adults with obesity, and for those who are overweight and have at least one weight-related condition such as diabetes, high blood pressure, high cholesterol, heart disease, or obstructive sleep apnea, according to the EMA. The treatment must be combined with diet and physical exercise.
The agency’s recommendation was based on results from a Phase 3 clinical trial involving 307 overweight or obese participants. Those who took the pill lost an average of 13.6% of their body weight over a period of nearly 15 months, compared to 2.2% in the control group that received a placebo.
Semaglutide belongs to the class of GLP-1 receptor agonists, drugs that mimic the action of the hormone of the same name, which is secreted by the intestine after eating and helps regulate blood sugar. They also act on the brain’s reward center, which controls food cravings.
The semaglutide pill is simpler to administer than the weekly injections that require refrigeration, a practical advantage that could attract tens of millions of new patients.
By the end of the next decade, the global market for GLP-1 obesity treatments is projected to reach $150 billion per year, according to Reuters.
In the United States, Novo Nordisk’s pill was approved in December, while Eli Lilly’s equivalent pill received the green light in April.
Novo’s pill must be taken every morning on an empty stomach, half an hour before eating or taking any other oral medication. Eli Lilly’s pill does not carry those restrictions.
