Eli Lilly's weight loss drug pill just got FDA approval

The Food and Drug Administration approved Eli Lilly $LLY -1.98%'s new oral weight loss drug Foundayo, the company said Wednesday, making it the market’s only GLP-1 pill that can be taken at any time of day without restrictions on food or water.

Orforglipron, the drug’s generic name, will be available as a once-daily tablet. Lilly plans to begin distribution through its LillyDirect platform, with broader rollout to retail pharmacies and telehealth providers to follow in the weeks after launch.

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Lilly has set cash-pay pricing on a sliding scale based on dose, with uninsured patients facing costs between $149 and $349 per month. A manufacturer coupon is available that may reduce the monthly expense to $25 for patients covered by commercial insurance.

Data from the ATTAIN-1 Phase 3 trial showed that patients who continued on the highest dose of Foundayo shed an average of 27.3 pounds — equivalent to 12.4% of their starting body weight — versus 2.2 pounds for placebo recipients, based on an on-treatment analysis. The trial enrolled more than 3,100 participants across multiple countries over 72 weeks.

Ricks told CNBC that because Foundayo is a small-molecule drug rather than a peptide like Zepbound, it sidesteps the more demanding manufacturing processes associated with injectable GLP-1 therapies and can be produced at the scale needed for a global rollout. Lilly has filed for regulatory clearance in more than 40 markets, he said.

With its FDA approval, Foundayo enters the market as a direct rival to Novo Nordisk’s Wegovy pill, which Novo reported had surpassed 600,000 prescriptions during March, according to CNBC. Both Lilly and Novo settled on $149 a month as the starting price for uninsured patients at the lowest dose — a figure that reflects commitments each company made to the Trump administration.

In head-to-head comparisons of trial data, Foundayo’s average weight reduction of approximately 12.4% falls short of the 16.6% average recorded in Novo Nordisk’s pivotal late-stage study. The Wegovy pill, by comparison, must be taken first thing in the morning on an empty stomach with only a small amount of water — constraints that Lilly has highlighted as a competitive disadvantage for its rival.

“We want people to be on the medicine that meets their health goals,” Ricks said. “If it has Lilly on the box, that’s the goal we have.”

Wall Street analysts tracked by FactSet estimate Foundayo could generate roughly $14.8 billion in annual sales by 2030 — about 60% of the nearly $24.7 billion projected for Lilly’s Zepbound injection over the same period, CNBC reported.

Foundayo carries warnings including a potential risk of thyroid tumors and thyroid cancer. The most common side effects include constipation, diarrhea, headache, nausea, and vomiting.

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