Novo Nordisk Wegovy pill gets EU nod with 16.6% weight loss

The European Medicines Agency recommended Novo Nordisk's Wegovy pill for approval, paving the way for the first oral GLP-1 obesity treatment in the EU.

The agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Friday for the oral version of semaglutide for weight management, according to the official announcement.

The recommendation is based on clinical trial data showing a mean weight loss of 16.6% in patients. The pill is already approved and sold in the United States, giving Novo an edge over competitors.

The approval intensifies the competition with U.S. rival Eli Lilly in the booming weight-loss drug market, which analysts project could reach $150 billion in the next decade.

The Wegovy tablet will be authorized for adults with obesity or those who are overweight and have at least one weight-related medical condition. The European Commission must now formally sign off on the approval before the drug can be marketed in the EU.

Pricing and insurance coverage will be determined at a country-by-country level.

Novo Nordisk's early entry into the oral treatment market in Europe is a significant advantage. Eli Lilly's competing pill, Foundayo, was launched in the U.S. in April but is not yet approved in the EU.

The CHMP recommendation is a major catalyst for Novo Nordisk, significantly expanding the addressable market for its blockbuster Wegovy franchise. Investors will now watch for the final European Commission approval and individual country pricing decisions.

This article is for informational purposes only and does not constitute investment advice.