The Committees vote is advisory, FDA will make the ultimate determination, and many of the most important questions remain unresolvedincluding how real-world evidence should be weighed, what quality standards should apply, and whether a guarded pathway can move existing use into a more regulated framework
The global SOUL trial of oral semaglutide on cardiovascular outcomes in people living with type 2 diabetes and high cardiovascular disease (CVD) risk showed a 14% reduction in major adverse cardiovascular events (MACE) compared to placebo
GLP-1 agonists address multiple aspects of type 2 diabetes - reducing blood sugar, promoting weight loss, and providing cardiovascular protection - making them a strong option for thorough diabetes management
I outline a way to play the picks and shovels of this issue, but it is also indicative of the fact that there is significant demand and further impact to be had for this theme - simply put, not enough people are on it yet
Ribeiro-Silva, J
But the commercial implications are already attracting serious attention because GLP-1s appear to affect far more than appetite
