The Food and Drug Administration on Wednesday approved Eli Lilly's new weight-loss pill, marking the second daily oral medication available to treat obesity in the United States. The drug, branded as Foundayo, received expedited approval under a program aimed at cutting drug approval times, with the agency reviewing the application in 50 days.

Foundayo contains orforglipron, a GLP-1 drug that works similarly to widely used injectable medications by mimicking a natural hormone that controls appetite and feelings of fullness. The pill is expected to begin shipping Monday, with insured patients potentially able to access it for $25 per month using a Lilly discount card. Cash prices will range from $149 to $349 monthly depending on dosage.

In clinical trials involving more than 3,000 adults with obesity, participants taking the highest 36-milligram dose lost an average of 11.2% of their body weight, or about 25 pounds, over 16 months. This compared to a 2.1% weight loss in the placebo group. However, the results were lower than those achieved with injectable versions - Lilly's Zepbound averages 21% weight loss while Novo Nordisk's injectable Wegovy achieves about 15%.

The approval creates direct competition with Novo Nordisk's oral Wegovy pill, which has generated more than 600,000 prescriptions since its December approval. Foundayo offers certain advantages as a small-molecule drug that can be taken without food restrictions, unlike Wegovy's peptide formulation that requires specific timing and an empty stomach.

Side effects in the orforglipron study were primarily gastrointestinal, leading 5% to 10% of participants to discontinue treatment compared to nearly 3% in the placebo group. Participants also showed improvements in waist circumference, blood pressure, and cholesterol levels. The new pill will be included in a Trump administration initiative to lower prices on GLP-1 drugs.