Wednesday, December 31

FDA approves Wegovy pill | Healthcare Finance News


Novo Nordisk has beaten Eli Lilly in releasing the first oral GLP-1 for weight loss in adults.

The Food and Drug Administration has approved Novo Nordisk’s once-daily Wegovy pill, the first oral GLP-1 medicine for obesity in the United States.

The full launch of the pill is expected in January.

The price for a 1.5-mg starter dose is $149 per month with savings offers, the company said. The pill is being produced in the United States, and there is a robust supply on hand.

It will be available in pharmacies and select telehealth providers in early January. Additional information on coverage and savings options for eligible patients, including other programs designed to help reduce out-of-pocket costs, will also be available at that time, Novo Nordisk said.

According to Novo Nordisk, a 64-week clinical trial with over 300 participants found that those with obesity or were overweight who completed the trial by taking the oral Wegovy pill once a day lost an average of 16.6% of their body weight, a similar amount to those who took the injectable form of Wegovy, which launched in 2021, on a weekly basis, according to ABC News.

The Wegovy pill is meant to be used with a reduced calorie diet and increased physical activity for adults with obesity, or who are overweight and who also have weight-related medical problems.

The Wegovy pill is also indicated to reduce the risk of major adverse cardiovascular events such as death, heart attack or stroke in adults with obesity or are overweight and with established cardiovascular disease.

WHY THIS MATTERS

In making the announcement, Novo Nordisk has beaten Eli Lilly, which manufactures Zepbound, in getting a pill version of a weight loss drug to the market, where only injectable medicines have been available. 

Two weeks ago, the FDA pressed internally for reviewers to speed up their evaluation of Eli Lilly’s weight‑loss pill, after the company pushed for a faster timeline, Reuters said.

Weight loss drugs are in high demand and have been relatively expensive. Insurance coverage varies. Commercial coverage can require prior authorization with approval granted only if an individual also has a health condition, such as diabetes. Some employers have opted against offering weight loss coverage in their commercial plans. 

The number of people with no commercial insurance coverage for Zepbound increased by over 180% in 2025, according to GoodRx. For those who have insurance coverage, over 90% still have to meet additional requirements for prior authorization.

Despite increased coverage for Wegovy in 2025, 88% of people with coverage still face restrictions such as prior authorization or step therapy, the GoodRx report said.

On Dec. 23, the Centers for Medicare & Medicaid Services unveiled a voluntary program to cover GLP-1 drugs for weight loss and diabetes under Medicaid and Medicare Part D plans. This followed President Donald Trump signing a deal in November to cut prices of GLP-1 weight‑loss drugs for Medicare and Medicaid programs, as well as for cash payers.

The Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model builds on emerging evidence that shows access to GLP-1 medications with access to evidence-based lifestyle supports achieves better long-term health outcomes, CMS said. 

THE LARGER TREND

The FDA approval of the Wegovy pill is based on the results from an OASIS 4 Phase 3 clinical trial, which was a 64-week medical study that included 307 adults with obesity or who were overweight with one or more weight-related comorbidities, without diabetes.

Results showed that if all patients stayed on treatment, people taking Wegovy pill once daily along with a reduced calorie diet and exercise achieved an average weight loss of about 17% (16.6%) versus about 3% (2.7%) with a placebo.

When looking at the efficacy regardless of all patients staying on treatment, an average weight loss of about 14% (13.6%) was achieved by people taking the Wegovy pill compared to about 2% (2.4%) for a placebo.

 

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