Apr. 14 at 3:56 PM
$NVO
Bad news for Foundayo, Lilly’s newly launch obesity pill:
According to an FDA letter, Eli Lilly has been asked to provide additional post-marketing safety data, including further assessment of potential liver injury.
The FDA is also requiring studies on:
• cardiovascular risk
• delayed gastric emptying
• drug levels in breast milk during lactation
This does not change the approval status, but it means the safety profile will remain under close regulatory review as the launch continues.