The Food and Drug Administration (FDA) recently approved Foundayo, a new daily pill designed to aid in weight loss. This approval introduces another option for individuals managing obesity, offering a pill-based alternative to currently available injectable medications.

A New Option in Obesity Treatment

Foundayo, manufactured by Eli Lilly, received a fast-track approval from the FDA. It will directly compete with the pill form of Wegovy, providing patients with a choice between pill options from both leading obesity medicine manufacturers. The availability of pill options is expected to appeal to a wider range of patients.

How Foundayo Differs from Existing Medications

Eli Lilly opted to develop a new active ingredient for Foundayo, known generically as orforglipron, rather than adapting the ingredient used in their popular injectable, Zepbound. “We’ve created a small molecule chemical which gets in your body very well,” explains Skovronsky. “It can mimic the effects of the peptide and can be taken more conveniently any time of day without any food or water restrictions.”

Unlike the Wegovy pill, which requires an empty stomach and a 30-minute fasting period for optimal absorption, Foundayo can be taken without such restrictions.

Clinical Trial Results

Data from a Lilly clinical trial showed that patients taking the highest dose of Foundayo for 72 weeks experienced an average weight loss of 27.3 pounds (12.4% of body weight), compared to 2.2 pounds (0.9%) for those receiving a placebo. Common side effects reported during trials included nausea, constipation, and diarrhea.

Industry Response and Efficacy Concerns

Novo Nordisk, the manufacturer of Wegovy, responded to the approval with a statement asserting the superiority of their product. “Not all GLP-1s are the same. Any reports claiming orforglipron is more effective than Wegovy pill for weight management are inaccurate and misleading,” stated Jamey Millar, executive vice president for U.S. operations of Novo Nordisk. The companies have not conducted a direct head-to-head trial comparing the two medications.

While clinical trials indicated Foundayo was slightly less effective than Wegovy, some clinicians believe its ease of use could lead to better patient adherence and ultimately, improved outcomes. Varney at UVA suggests the convenience of the pill may be advantageous for patients with complex medical regimens.

Cost and Accessibility

The starting price for Foundayo is $149 per month for cash-paying customers. Eli Lilly is working to establish insurance coverage, with potential copays as low as $25 per month with a savings card for those with commercial insurance. Medicare recipients may be eligible for a $50 monthly price starting in July. Medicaid coverage is still pending.

The company anticipates sufficient supply to meet demand, with the medication expected to be available on pharmacy shelves within “a week or two.”