Eli Lilly’s obesity pill was approved by the Food and Drug Administration on Wednesday, setting it up for fierce competition against Novo Nordisk’s new Wegovy pill as more people seek alternatives to GLP-1 injections.
Lilly’s drug, which is called orforglipron and will be marketed as Foundayo, was approved under the FDA’s new commissioner’s voucher program, which grants speedy reviews to drugs that are aligned with national health priorities.
In Phase 3 trials, Lilly tested Foundayo in capsules with doses ranging up to 36 mg. The FDA approved the drug as tablets, with doses ranging up to 17.2 mg, which Lilly said are equivalent to the capsule doses.
Novo and Lilly led the growth of the obesity drug market with the injectable GLP-1 medications Wegovy and Zepbound. The drugmakers are now headed into a new era with pills. While the daily oral treatments are generally seen to be less effective than the weekly injectables, they’re still expected to have wide appeal since many people don’t want to use needles, and the pills can be easily distributed and don’t require cold storage.
Investors are hoping that orforglipron will be a major growth catalyst for Lilly. The Wegovy pill, as an oral peptide that’s harder for the body to absorb, must be taken in the morning at least 30 minutes before any food or drinks other than water, restrictions that can be unappealing to many people. Orforglipron doesn’t carry any such restrictions.
However, with a head start following the Wegovy pill’s approval in December, Novo has seen rapid adoption of its pill, which may dent the uptake of Lilly’s drug.
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Price will be a big factor in the competition. Lilly last year said it plans to sell its pill at prices from $149 a month to $399 a month in the cash market, where patients buy drugs directly without using insurance. But Novo then launched the Wegovy pill at a cash price of up to $299 a month, undercutting Lilly. Now, Lilly has lowered its price, saying on Wednesday that it will sell the pill at up to $299 a month if patients continually renew their prescription.
In terms of efficacy, the Wegovy pill led to 13.6% weight loss in a 64-week Phase 3 trial, slightly more than the 11.2% weight loss that orforglipron showed in its 72-week study.
Novo has also argued that there’s much more evidence of the safety of its pill, since it contains the same ingredient as injectable Wegovy, which has been on the market for several years. The pill is also approved to cut the risk of cardiovascular complications, since the injection had been proven effective for such treatment in a large study.
Lilly’s pill, a small molecule, was shown to be generally safe in its trials, with the most common side effects being nausea, vomiting, and diarrhea, similar to other GLP-1 drugs. With small molecules, researchers are always concerned about the risk of liver damage, since those types of drugs are metabolized in the liver, but orforglipron didn’t show liver risks in its studies.
However, the voucher program that the pill was approved through has been controversial, with agency insiders saying it’s been a vehicle for political interference. Lilly received a voucher as part of its deal with the White House to lower the prices of its obesity drugs in certain settings.
Afterward, Reuters reported that Lilly tried to pressure the agency to deliver a faster answer on whether it considers Lilly’s applications complete. A Lilly spokesperson told Reuters the company expected the FDA to conduct a fulsome review of the drug and make a science-based decision.
