Key Highlights
- Foundayo generated 1,390 prescriptions during its first full week in the U.S., ending April 10.
- Competitor Novo Nordisk’s oral Wegovy achieved 3,071 prescriptions within its initial four-day period following its January 5 launch.
- Clinical trial data from 2,700 patients demonstrated Foundayo reduced cardiovascular event risk by 16% compared to insulin glargine.
- The trial also revealed a 57% reduction in all-cause mortality among participants taking Foundayo.
- Eli Lilly shares climbed approximately 3% during premarket hours after the data announcements.
Eli Lilly’s recently launched obesity medication Foundayo is generating initial prescription activity, although it currently lags behind Novo Nordisk’s competing oral Wegovy in early market uptake.
The FDA granted approval for Foundayo on April 1 as a weight management treatment. Through LillyDirect, prescriptions became available right away, with deliveries commencing April 6. Wider distribution across retail pharmacies and telehealth platforms throughout the United States began April 9.
By the week ending April 10, IQVIA tracking data showed Foundayo accumulated 1,390 prescriptions nationwide, according to analyst reports. In contrast, Novo Nordisk’s oral Wegovy formulation captured 3,071 prescriptions during merely its first four days following its January 5 market entry.
During that same tracking period, Novo’s oral Wegovy recorded 113,354 prescriptions across the U.S., representing an increase from the previous week’s 105,366.
Company representatives have cautioned investors about anticipated fluctuations in weekly and daily market share metrics during the initial launch phase. Guggenheim analysts note that these weekly totals encompass retail pharmacy fills along with samples distributed through telehealth services, LillyDirect, and mail-order channels.
Following the data release, LLY shares increased nearly 3% before market opening.
Clinical Trial Demonstrates Cardiovascular and Survival Advantages
Concurrent with prescription figures, Lilly published findings from an advanced-phase cardiovascular outcomes study that enrolled 2,700 participants with type 2 diabetes and obesity facing heightened cardiovascular risk.
Compared to insulin glargine—a long-acting insulin marketed as Sanofi’s Lantus and Lilly’s Basaglar—Foundayo decreased the combined risk of heart attack, stroke, or cardiovascular-related death by 16%.
Additionally, the medication demonstrated a 57% reduction in mortality from all causes during the study period. At the 52-week mark, Foundayo also delivered improvements in A1C measurements and body weight reduction.
The FDA had previously requested supplementary post-approval studies addressing potential hepatotoxicity concerns. This trial incorporated liver safety monitoring, and Lilly reported finding no evidence of liver-related safety issues. These findings aligned with outcomes from previous clinical investigations.
According to RBC Capital Markets analyst Trung Huynh, the liver safety findings should alleviate concerns about Foundayo presenting distinctive hepatic risks relative to competing treatments such as oral Wegovy.
Company Pursues Diabetes Indication for Foundayo
Lilly intends to leverage these trial results in seeking FDA authorization of Foundayo for type 2 diabetes treatment. The pharmaceutical company announced plans to file the application before the conclusion of Q2, utilizing a Commissioner’s National Priority Review Voucher to expedite the regulatory review timeline.
Following the FDA’s weight loss approval for Foundayo this month, competition has intensified with Novo Nordisk, whose oral Wegovy has maintained market presence since January.
Novo’s oral Wegovy formulation tallied 113,354 U.S. prescriptions during the week that concluded April 10.
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