AstraZeneca Submits Atacand For Heart Failure: First ARB To Show Mortality Benefit
This article was originally published in The Pink Sheet Daily
Executive Summary
Combination use with ACE inhibitors will likely be an issue for the Atacand sNDA; the efficacy seen in AstraZeneca’s CHARM studies conflicts with the Val-HeFT data for Novatis’ angiotensin-II receptor blocker Diovan, which showed no added benefit.
You may also be interested in...
AstraZeneca's Atacand Adds ACE Inhibitor Combo Claim For Heart Failure
Angiotensin receptor blocker is the first in its class to gain the indication. FDA's approval is in line with the Cardio-Renal Advisory Committee's unanimous recommendation in February.
AstraZeneca's Atacand Adds ACE Inhibitor Combo Claim For Heart Failure
Angiotensin receptor blocker is the first in its class to gain the indication. FDA's approval is in line with the Cardio-Renal Advisory Committee's unanimous recommendation in February.
AstraZeneca's Atacand Heart Failure Indication Clears FDA Ahead Of Cmte. Review
The agency approves candesartan for treatment of heart failure to reduce cardiovascular mortality and hospitalizations. The angiotensin receptor blocker is the first product in its class to receive the claim. Approval comes two days before an FDA advisory panel review.