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3w ago

Lilly’s Oral Drug Foundayo Matches Insulin on Heart Safety in Major Diabetes Trial

The finding sets up a near-term FDA filing under a priority review voucher.

The FDA requires Eli Lilly to conduct post-marketing safety studies on its recently approved obesity pill, Foundayo. Credit: Visual Generation / Shutterstock.com.
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Overview

  • ACHIEVE-4, a global study of more than 2,700 people with type 2 diabetes, met its heart safety goal versus insulin glargine with a 16% lower rate of major cardiac events.
  • Patients on Foundayo saw larger drops in A1C at 52 weeks and lost weight rather than gaining it, with both effects maintained through two years.
  • A pre-planned look at deaths found a 57% lower risk for those on Foundayo, which Lilly reported as nominally significant and subject to further review.
  • Side effects tracked with the GLP-1 class, including nausea and diarrhea, and 10.6% stopped treatment due to adverse events during the first year.
  • Lilly said it will seek a U.S. type 2 diabetes indication by the end of the second quarter using the Commissioner’s National Priority Review Voucher.