Right after the FDA flagged safety concerns for Eli Lilly’s newly approved obesity pill, the pharma posted diabetes data demonstrating a clean safety profile and revealed plans to seek approval in the indication.
Eli Lilly is chasing an FDA nod for Foundayo in diabetes after the drug was tied to a reduction in cardiovascular events compared to long-acting insulin. But the real headline of the readout was that Lilly observed no liver safety signals, just days after the FDA flagged such concerns for the pill’s obesity indication.
In the phase 3 ACHIEVE-4 study, Foundayo cut the risk of cardiovascular death, heart attack, stroke or chest pain hospitalizations by 16% compared to insulin glargine, according to a Thursday release. The study, which recruited more than 2,700 people with type 2 diabetes and obesity or overweight, met its main goal by demonstrating a non-inferior risk of major adverse cardiovascular events compared to insulin.
The 52-week trial also found the risk of all-cause death to be 57% lower for participants receiving Foundayo, with the GLP-1 pill also tied to 16% lower A1C levels compared to insulin.
Analysts were bullish on the new data, with Leerink Partners calling the results “outstanding” in a Thursday note.
Importantly, the 52-week trial showed no signs of hepatic safety signals or drug-induced liver injury (DILI), which should assuage FDA concerns about “unexpected” cases of major adverse cardiovascular events and DILI. After approving the drug for weight loss at the start of the month, the agency had called for a post-marketing clinical trial to assess potential safety risks—a requirement that ACHIEVE-4 seems to have mostly fulfilled.
At RBC Capital Markets, analysts deemed the cardiovascular outcomes “strong” and said, “the efficacy and safety profile support an approvable dataset.”
“This data should allay fears that Foundayo faces unique liver safety risks versus competitors like oral Wegovy,” the analysts wrote. “With focus on early TRx tracking potentially driving market overreactions—we view ACHIEVE-4 as a positive catalyst to refocus investors on Foundayo’s clinical profile.”
“Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile,” Thomas Seck, senior vice president of product development for Lilly Cardiometabolic Health, said in a statement.
“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,” Seck said. “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.”
Gastrointestinal-related adverse events (AEs) were the most common, and the trial’s discontinuation rate was up to 10.6%.
The phase 3 results set Foundayo up “very well” for a global launch as a once-daily oral pill alternative for diabetes to daily insulin injections, Leerink Partners said, highlighting the 57% all-cause death improvement and clean safety profile.
The analyst now anticipates an FDA greenlight in diabetes in the second half of this year versus its previous expectation of next year.
Foundayo was approved in obesity on April 1 under the FDA’s new Commissioner’s National Priority Voucher Program, which aims to shorten review times for products meeting certain national priorities from 10-12 months to 1-2 months. Lilly plans to pursue the new diabetes indication via the same program.
