The US Food and Drug Administration (FDA) has published draft guidance for sponsors developing drugs and biologics for weight reduction for patients who are obese. The guidance focuses on using body mass index (BMI) as a key metric and is based on the agency’s current thinking on effective treatments for obesity.
The draft guidance is intended to update a 2007 document on developing products for weight management. Weight-loss drugs such as Ozempic (semaglutide) and Zepbound (tirzepatide) have become blockbuster drugs in recent years, and FDA said it revised the guidance to account for what it has learned more about such drugs in the time since the original guidance was issued…
