Regulatory Approval

AstraZeneca PLC
23 February 2005



           FDA APPROVES ASTRAZENECA'S ATACAND(R) (CANDESARTAN CILEXETIL) 
                        FOR THE TREATMENT OF HEART FAILURE



AstraZeneca today announced that the US Food and Drug Administration (FDA) has
approved its angiotensin receptor blocker (ARB) ATACAND(R) (candesartan
cilexetil) for the treatment of heart failure (New York Heart Association Class
II-IV and ejection fraction less than or equal to 40 percent) to reduce the risk
of death from cardiovascular causes and reduce hospitalisations from heart
failure.  ATACAND is the first ARB in the US to receive an indication for
reducing both cardiovascular mortality and hospitalisations for heart failure.



The US approval was primarily based on results from Candesartan in Heart Failure
Assessment of Reduction in Mortality and morbidity Alternative Trial
(CHARM-Alternative), which examined the effect of ATACAND (n= 1013) compared to
placebo (n=1015) in 2028 heart failure patients who were intolerant to ACE
inhibitors, but were receiving other standard heart failure therapy.  In most
cases, the starting dose of ATACAND was 4 mg once daily, which was doubled every
two weeks up to the sixth week.  Patients received the highest dose tolerated up
to the target dose of 32 mg once daily.    Patients were evaluated at 2, 4, and
6 weeks; at 6 months; and every 4 months after until the end of the trial (34
months on average).  The primary endpoint was time to either cardiovascular
mortality or hospitalisation for heart failure.  The trial demonstrated that, in
these CHF patients, the use of ATACAND resulted in a 23 percent (p less than
0.001) relative risk reduction in cardiovascular death or heart failure
hospitalisation (406 events in the placebo arm compared to 334 events in the
patients receiving ATACAND), with both components contributing to this effect.



This finding was supported by a second study of 2548 subjects (CHARM-Added) with
New York Heart Association (NYHA) Class II-IV heart failure and ejection
fraction less than or equal to 40 percent, in which subjects were already on ACE
inhibitors.  Together, in these studies, patients on ATACAND had a 15 percent
lower risk of cardiovascular mortality (p=0.005).   In these studies, symptoms
of heart failure as assessed by NYHA functional class were also improved (p less
than 0.001).



Heart failure, also called chronic heart failure or CHF, is a condition in which
the heart is unable to pump blood adequately to the rest of the body.  It is a
serious, progressive, debilitating condition and frequently leads to a fatal
outcome.  Many heart failure patients have impaired left ventricular systolic
function and this is the population that has been studied in most previous heart
failure trials.  In these patients, the heart's ability to function as a pump is
compromised, as evidenced by a reduced ejection fraction, which is the
percentage of blood ejected by the heart with each contraction.  The normal
heart ejects more than 50 percent of the blood in the left ventricle with each
beat.  Common causes of heart failure include coronary artery disease, heart
attacks (or myocardial infarction), high blood pressure (or hypertension), and
heart disease of unknown origin (or cardiomyopathy).



New York Heart Association (NYHA) Classification is a widely used and validated
measure of symptomatic limitation in CHF.  Class I: No limitation. Ordinary
physical exercise does not cause fatigue, dyspnoea (breathlessness) or
palpitations.  Class II: Slight limitation of physical activity. Comfortable at
rest but ordinary physical activity results in symptoms.  Class III: Marked
limitation of physical activity. Comfortable at rest but less than ordinary
activity results in symptoms.  Class IV: Unable to carry out any physical
activity without discomfort. Symptoms present even at rest with increased
discomfort with any physical activity.



The American Heart Association estimates that nearly 5 million Americans are
currently living with heart failure, and more than half a million new cases are
diagnosed each year.



The recommended initial dose of ATACAND for the treatment of heart failure is 4
mg once daily.  The target dose is 32 mg once daily, which is achieved by
doubling the dose at approximately two-week intervals, as tolerated by the
patient.



In November 2004, AstraZeneca announced that the European Mutual Recognition
Variation Procedure (MRP) evaluating the use of ATACAND for the treatment of
patients with heart failure and impaired left ventricle systolic function had
been completed.    Worldwide sales of ATACAND totalled $879 million for 2004.



Candesartan Cilexetil is marketed by AstraZeneca under trademark ATACAND(R).
ATACAND(R) is manufactured under agreement from Takeda Pharmaceutical Company
Limited.



23rd February 2005



Media Enquiries:
Edel McCaffrey,         Tel: [phone]
Steve Brown,            Tel: [phone]

Investor Relations:
Mina Blair,             Tel: [phone]
Jonathan Hunt,          Tel: [phone]



-Ends-


                      This information is provided by RNS
            The company news service from the London Stock Exchange