Will Atacand be Approved for Treating Congestive Heart Failure?

AstraZeneca’s Atacand is due to be reviewed by Food and Drug Administration’s (FDA) Cardiovascular & Renal Drugs Advisory Committee on February 24, 2005 for the treatment of Congestive Heart Failure (CHF). Find out the three supporting claims for this new indication.
Will Atacand be Approved for Treating Congestive Heart Failure?
Atacand is currently on the market and being used for treating hypertension. AstraZeneca is now seeking to market the drug for Congestive Heart Failure for the 4 mg, 8 mg, 16 mg and 32 mg doses.

Clinical studies performed by AstraZeneca support three claims:

  • The first claim is that Atacand "reduces the risk of cardiovascular mortaility or heart failure hospitalization when added to an angiotension-converting enzyme inhibitor-containing regimen in Congestive Heart Failure patients with left ventricular systolic dysfunction."


  • The second claim includes a reduction in the same risks in the same group of Congestive Heart Failure patients, but "as a primary reninangiotensin-aldosterone system modulating treatment."


  • The third claim is that Atacand reduces the "frequency of hospitalizations for heart failure in Congestive Heart Failure patients with preserved left ventricular systolic dysfunction."


    • Updates on the review of AstraZeneca’s Atacand can be found on FDAAdvisoryCommittee.com.

    Source: FDAAdvisoryCommittee.com

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    Discussion:

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       By Stacey Lloyd
    Published: 1/18/2005
     
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