Re: FDA approves "empagliflozin" for reducing risk of cardiovascular death, hospitalization among adult HFpEF patients
posted on
Apr 05, 2022 12:07PM
primary endpoitn was 'composite' so FDA granted approval based on primary composite endpoints.
FDA doesn't consider seriously secondary and/or exploratory outcomes if primary endpoint doesn't meet.
Empagliflozin is approved for pEF which doesn't really have treatments as opposed rEF which has many treatments. So, pEF is indeed a good population to go after (for RVX).
But, currently RVX is being tiraled in population with diabetes not heart failure. These are 2 diff. populations.