WASHINGTON, January 8, 2024 — The Food and Drug Administration on Monday approved an oral version of Novo Nordisk’s weight loss medication Wegovy, potentially reshaping how millions approach obesity treatment. This approval ignites the next phase of a fierce competition with Eli Lilly for dominance in the rapidly expanding market for weight loss drugs.
A Pill for Weight Loss: A Game Changer?
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The approval signals a major shift, offering a more convenient alternative to weekly injections, and could significantly increase access to these medications.
- Combined, injectable and oral GLP-1 drugs are projected to generate over $100 billion in annual sales by 2030, according to Wall Street analysts.
- Novo Nordisk will launch oral Wegovy in early January, with Eli Lilly’s orforglipron potentially following soon, aided by an FDA “national priority” voucher.
- Phase 3 trials showed that the approved 25 milligram dose of oral Wegovy helped individuals with obesity or related health issues lose an average of 14% of their body weight over 71 weeks.
- The White House has pressured the FDA to expand access to obesity medications, and Novo and Lilly have agreed to price starter doses of their oral drugs at $149 a month.
For years, weight loss medication has largely meant weekly injections. While effective, that delivery method isn’t for everyone. The arrival of a pill form, even if somewhat less potent, promises to broaden access and appeal. “The pill is here,” declared Novo Nordisk CEO Mike Doustdar in a statement. “No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the U.S.”
Political Pressure and Pricing Negotiations
The push for more obesity treatments and improved access hasn’t happened in a vacuum. President Trump, among others, has urged the FDA and other federal health agencies to prioritize this area. This pressure culminated in agreements between Novo Nordisk and Eli Lilly with the White House to lower medication costs for some Medicare beneficiaries and cash-paying customers. As part of these negotiations, both companies committed to pricing the initial doses of their oral medications at $149 per month.
Novo Nordisk’s Road to the Pill
The approval of oral Wegovy represents a recovery for Novo Nordisk, which recently faced setbacks that impacted its stock price and ceded its leading position to Eli Lilly. The development of the pill stemmed from a strategic pivot, utilizing a higher dose of the oral GLP-1 medication it already sells as Rybelsus for diabetes. Successful Phase 3 trials were completed in 2023, but regulatory submissions were initially delayed as the company struggled to meet the high demand for its existing GLP-1 drugs.
Novo Nordisk also encountered challenges with an experimental dual-acting injectable drug and another oral drug candidate, both of which yielded disappointing trial results. However, the company continued to gather data on oral Wegovy and ultimately proceeded with its application to the FDA.
How Does it Work? The Science Behind the Pill
Novo Nordisk’s Phase 3 trials, known as OASIS, tested oral Wegovy at doses up to 50 milligrams daily. The 25 milligram dose approved Monday demonstrated an average weight loss of 14% over 71 weeks for individuals with obesity or weight-related health complications, and 17% for those who fully adhered to the treatment plan.
Eli Lilly’s orforglipron, in contrast, is a “small molecule” drug, meaning it’s chemically synthesized and doesn’t require the same complex manufacturing process. Clinical trials for orforglipron tested a maximum daily dose of 36 milligrams.
