By Leah Douglas and Christy Santhosh April 1 (Reuters) - The U.S. FDA on Wednesday approved Eli Lilly's weight-loss pill, setting up its next battle with rival Novo Nordisk for the millions of
Lilly's weight-loss pill wins US approval, sets up next battle with rival Novo Nordisk
FDA Approval and Market Impact
By Leah Douglas and Christy Santhosh
April 1 (Reuters) - The U.S. FDA on Wednesday approved Eli Lilly's weight-loss pill, setting up its next battle with rival Novo Nordisk for the millions of Americans seeking highly effective GLP-1 medicines.
About Foundayo: Lilly's New Weight-Loss Pill
The Lilly drug, orforglipron, which will be sold under the brand name Foundayo, is a once-daily oral medication that targets the GLP-1 hormone. Patients taking the drug in trials lost 12% to 15% of their body weight.
Availability and Pricing
Lilly said it will begin selling Foundayo on April 6 through its LillyDirect program at a cost of $149 per month for the lowest dose for self-pay customers, on par with Novo's pill. Soon after, it will be available through retail pharmacies and telehealth providers, the Indianapolis-based company said.
Global Expansion Plans
Lilly CEO David Ricks told reporters the pill would be suitable for patients seeking to lose weight or to maintain weight loss, and that the company has submitted the drug for approval in over 40 countries.
"We do expect approvals yet this year in several major markets. The Gulf states are one of those areas that tend to move a little quicker, so that would be one," Ricks said.
Lilly vs Novo: The Competitive Landscape
LILLY VS NOVO
The approval, fast-tracked under the Food and Drug Administration's new voucher program, puts Lilly back in direct competition with Danish drugmaker Novo Nordisk.
Novo was first with its injectable GLP-1 medicines, including Ozempic for diabetes and Wegovy for obesity, but Lilly now dominates that U.S. market. Novo also gained the first-to-market advantage in pills, when it launched oral Wegovy in January to strong demand.
Product Differences
Lilly's pill can be taken at any time of day with or without food, compared with the Wegovy pill, which must be taken first thing in the morning and 30 minutes before any food, water or other medications.
Analyst Insights
"In the early innings of the launch, investors will be following closely to see if Foundayo's lack of a food effect drives any difference in patient uptake," BMO analyst Evan Seigerman said in a research note.
Shares of Lilly climbed 6%, while U.S.-listed shares of Novo fell slightly after the approval announcement.
Pills vs Injectables: Market Trends and Patient Preferences
PILLS VS INJECTABLES
Most oral Wegovy patients are taking a GLP-1 for the first time, an indication that the pills can capture a share of the weight-loss market not served by injectables, said Novo Nordisk U.S. operations executive Jamey Millar.
Millar said oral Wegovy patients have not had issues taking the pill according to instructions and that affordability and side effects are more significant factors for patients when choosing a drug.
Market Forecast
Oral weight-loss drugs are not expected to fully replace injectables, which can deliver greater weight loss, but analysts estimate pills could capture around 20% of the market by 2030.
Clinical Trial Results
In a 72-week late-stage trial, orforglipron helped overweight people lose about 12% of their body weight, with weight loss plateauing for most patients. In a previous 36-week midstage trial, orforglipron was shown to reduce body weight by nearly 15%.
The most commonly reported side effects were mild-to-moderate gastrointestinal issues such as nausea and vomiting.
Regulatory Details and Safety Information
Foundayo's label comes with a boxed warning - the FDA's most serious label addition - advising of an increased risk of thyroid C-cell tumors. Novo's oral and injectable Wegovy carry the same warning.
Lilly's pill was granted a voucher under the Commissioner's National Priority voucher program, which aims to fast-track FDA decisions for drugs with critical public health or national security impact.
Lilly received the voucher as part of a deal with the Trump administration to lower the prices of its weight-loss medicines for government programs and cash-paying patients.
FDA Review Process
FDA Commissioner Marty Makary told reporters the Lilly pill review was as thorough as the traditional longer process would have been. "What we're doing is convening the different people at the agency that review parts of the application," he said.
(Reporting by Leah Douglas in Washington and Christy Santhosh in Bengaluru; additional reporting by Ahmed Aboulenein; Editing by Daniel Wallis, Caroline Humer and Bill Berkrot)
