Shots:
- The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications planned
- Approval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed Kerendia (QD) vs PBO in pts (n=~6000) with HF as well as LVEF of ≥40%, who received diuretic therapy for ≥30 days before randomization
- Study showed decrease in composite CV deaths & total HF events, regardless of background therapy, comorbidities, or hospitalization status. Data was presented at ESC Congress 2024 & was published in The NEJM
Ref: Bayer | Image: Bayer | Press Release
Related News:- Bayer Reports the US FDA’s NDA Submission of Gadoquatrane for Contrast-Enhanced MRI
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
