Reuters also reports that shares for Eli Lilly rose 1.6% before the markets opened on Friday, April 17th (the same day this news broke).
Analysts are closely watching the market, as oral versions of the medications are entering alongside the traditional injectables. So far, injectable versions of weight loss medications still lead sales.
Earlier this week, FDA announced that despite Foundayo’s approval, the agency still required post-approval safety studies for the medication. The agency’s approval letter detailed a series of risks that it believed it could not fully characterize based on existing data. These risks include:
- Heart attack
- Strong
- Drug-induced liver injury
- Delayed stomach emptying
FDA also requested 15 years of thyroid cancer risk data, which is consistent with the existing warnings on previous iterations of Wegovy and Zepbound. However, the agency also requires Lilly to establish a registry of children and pregnant women taking the medication to treat obesity to monitor outcomes.
In response to FDA’s requirements,2 Lilly issued a statement on the safety profile for Foundayo. In the statement, senior vice president of product development at Lilly Cardiometabolic Health Thomas Seck, MD, said, “Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile. ACHIEVE-4 adds a new dimension to that evidence—cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk. Together with the simplicity of a once-daily pill that requires no food or water restrictions, we believe Foundayo could be an important new treatment option for people with type 2 diabetes."
Lilly also plans to submit Foundayo for approval to treat Type 2 diabetes by the end of the second quarter 2026 using a Commissioner’s National Priority Review Voucher. Foundayo was approved for obesity under the same priority program.
At the time of the drug’s approval, Lilly’s chair and CEO David Ricks said, “We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications. As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world."
Sources
- Lilly's obesity pill draws 1,390 US prescriptions in launch week. Reuters. April 17, 2026. https://www.reuters.com/legal/litigation/lillys-foundayo-hits-1390-prescriptions-debut-week-2026-04-17/
- ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health.Eli Lilly. April 16, 2026. https://investor.lilly.com/news-releases/news-release-details/achieve-4-longest-phase-3-study-lillys-foundayo-orforglipron