Novo Nordisk Submits Oral GLP-1 Obesity Drug for FDA Approval, Facing Competition from Eli Lilly

In a significant development for the pharmaceutical industry, Novo Nordisk has submitted its oral version of the injectable obesity treatment Wegovy to the U.S. Food and Drug Administration (FDA) for approval. This move comes nearly two years after the company reported successful results from a phase 3 trial of the oral semaglutide formulation.

Novo Nordisk's Strategic Shift

The FDA submission, confirmed by a company spokesperson, marks a pivotal moment for Novo Nordisk as it seeks to expand its portfolio of weight loss treatments. The timing of the submission is noteworthy, as it follows a period of intense focus on meeting the surging demand for Wegovy and the diabetes drug Ozempic.

Novo Nordisk's decision to prioritize the oral semaglutide submission appears to be influenced by recent setbacks in other areas of its pipeline. The company's dual-action obesity pill, CagriSema, which was once touted as having the potential to trigger 25% weight loss, produced disappointing results in a second phase 3 trial. The treatment showed only a 16% weight reduction, leading to a 36% drop in Novo Nordisk's share price.

Competition Heats Up in the Obesity Treatment Market

The submission of oral semaglutide for FDA approval comes at a time of increased competition in the obesity treatment market. Eli Lilly, a major rival, has reported strong trial results for its own GLP-1 pill, orforglipron. This development has put additional pressure on Novo Nordisk to secure a first-to-market advantage in the oral weight loss treatment sector.

The landscape of the obesity treatment market is rapidly evolving, with both Novo Nordisk and Eli Lilly vying for dominance in the oral GLP-1 segment. The outcome of Novo Nordisk's FDA submission could significantly impact the company's position in this competitive field.

Expanding the GLP-1 Portfolio

Novo Nordisk's oral semaglutide submission is part of a broader strategy to expand its GLP-1 portfolio. The company already markets Rybelsus, an oral semaglutide treatment for diabetes patients, which has shown strong sales growth. In 2024, Rybelsus generated sales of 23.3 billion Danish kroner ($3.4 billion), representing a 26% year-over-year increase.

Recently, Novo Nordisk has also submitted Rybelsus for a label expansion to help heart disease patients reduce their risk of cardiovascular events. This multi-pronged approach demonstrates the company's commitment to leveraging its GLP-1 expertise across various therapeutic areas.

As the pharmaceutical industry awaits the FDA's decision on oral semaglutide for obesity treatment, the outcome could have far-reaching implications for both Novo Nordisk and the broader market for weight loss medications. The company is expected to provide more information about the submission during its quarterly results presentation on May 7, 2025.