The U.S. Food and Drug Administration has approved a new GLP-1 for weight loss, adding a new once-daily pill to the pharmaceutical competition over the popular drugs.
Eli Lilly developed the new drug Foundayo, the brand name for Orforglipron, a daily oral GLP-1 pill to treat obesity. Like other GLP-1 drugs, it mimics a hormone important for appetite, digestion and insulin regulation to treat type 2 diabetes and manage weight.
Foundayo hits the market Monday, offering a challenge to rival Novo Nordisk’s Wegovy, another weight-loss pill to replace the weekly self-injections of other GLP-1 drugs.
Foundayo will be available by prescription.
It won FDA approval with historic speed. The review lasted just 50 days under the new Commissioner’s National Priority Voucher, the fastest approval of a new drug of its kind since 2002.
Eli Lilly CEO David A. Ricks called the new pill “obesity care designed for the real world.”
“Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn’t serious enough for treatment. We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications,” he said in a statement.
In clinical studies, participants lost an average of about 25 pounds over 72 weeks. In a clinical trial, people who took the highest dose lost an average of 27.3 pounds compared to 2.2 pounds with a placebo.
“People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment,” said Deborah Horn, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston in an Eli Lilly press release. “With Foundayo, we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials — addressing both the clinical realities of obesity and the practical challenges patients face every day.”
Foundayo will be available in six different doses: 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg tablets.
People with health care insurance may pay as little as $25 per month with the Foundayo savings card, which is competitive with Wegovey in price. Those opting for self-pay can access Foundayo starting at $149 per month for the lowest dose.
People with Medicare Part D may be able to get Foundayo for $50 per month, beginning in July, according to Eli Lilly.
The pill can cause serious reactions, such as pancreatitis, hypoglycemia, and tumors in the thyroid, including thyroid cancer, which is a standard warning for the entire GLP-1 drug class.
In clinical trials of Foundayo, no cases of medullary thyroid cancer were reported.
• Juliet La Sala can be reached at jlasala@washingtontimes.com.
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