By Leah Douglas and Christy Santhosh
April 1 (Reuters) – The U.S. FDA on Wednesday approved Eli Lilly’s weight-loss pill, setting up the next battle with Novo Nordisk for the millions of Americans seeking highly effective GLP-1 medicines.
The Lilly drug, orforglipron, which will be sold under the brand name Foundayo, is a once-daily oral medication that targets the appetite-suppressing GLP-1 hormone.
Lilly said the drug will be available for shipping beginning April 6 through its LillyDirect program and cost $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.
The approval gives Lilly solid footing in the emerging obesity-pill market after overtaking Novo Nordisk in the competition for injectables.
The Danish drugmaker was first-to-market with GLP-1 medicines, including Ozempic for diabetes and Wegovy for obesity, but has fallen behind amid intense competition from Lilly and pressure from compounded versions of the medicines.
Lilly’s pill has a convenience advantage over Novo’s. It can be taken without any restrictions and at any time of day, compared with the Wegovy pill, which must be taken first thing in the morning and 30 minutes before any food, water or other medications.
Lilly’s blockbuster injection tirzepatide, sold as Mounjaro for diabetes and Zepbound for weight loss, has a dual mechanism of action that mimics the GLP-1 and GIP hormones.
Shares of Lilly climbed nearly 5%, while U.S.-listed shares of Novo fell nearly 2% after the approval announcement.
BODY-WEIGHT REDUCTION OF 12%-15%
Oral weight-loss drugs are not expected to fully replace injectables, but analysts estimate pills could capture around 20% of the market by 2030, particularly among patients who prefer pills to self-administered shots.
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% without an apparent plateau.
The most commonly reported side effects were mild-to-moderate gastrointestinal issues such as nausea and vomiting.
Foundayo’s label comes with a boxed warning – the Food and Drug Administration’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.
PILL FAST-TRACKED UNDER TRUMP DEAL
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 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 and Bill Berkrot)
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