FDA Approves Oral GLP-1 Pill Foundayo (orforglipron)
The U.S. Food and Drug Administration approved Foundayo (orforglipron), an oral GLP-1 weight loss medication from Ely Lilly.
This marks the fifth approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. This decision represents a historic milestone as the first new molecular entity (NME) approved under the program and the fastest approval of an NME since 2002.
“The approval of orforglipron is another example of how the FDA’s CNPV pilot program has been able to more quickly bring effective treatments to Americans. Individuals who are overweight or obese now have an additional option to help with weight loss — a GLP-1 receptor partial agonist pill which does not need to be taken on an empty stomach,” said Acting Center for Drug Evaluation and Research (CDER) Director Tracy Beth Høeg, M.D., Ph.D. “The CDER review team delivered a thorough, high-quality product review and benefit-risk analysis, while simultaneously taking months off the standard filing-to-decision time.”
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Foundayo is approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
Foundayo is a glucagon-like peptide-1 (GLP-1) receptor agonist in tablet form that should be taken orally once daily. Starting dosage is 0.8 mg, which should be increased to 2.5 mg after at least 30 days and then to 5.5 mg after another 30 days. The dosage may be increased further to 9 mg, 14.5 mg, or 17.2 mg after at least 30 days at each level based on treatment response and tolerability.
Two randomized, double-blind, placebo-controlled trials in adults with obesity or with overweight and one or more weight-related comorbidities supported the approval of Foundayo. In these trials, 72 weeks of treatment with Foundayo, in combination with a reduced calorie diet and increased physical activity, resulted in a statistically significant and clinically meaningful reduction in body weight in the Foundayo treated groups compared with the placebo group.