A new drug, Crestor, approved Monday, focuses on treating heart disease for the masses with healthy cholesterol levels. Millions of people with high levels of C-reactive protein (CRP) are in a different group who suffer from coronary heart disease. CRP is a plasma protein, that when increased in the blood, causes inflammation in the heart. Heart disease treatment drugs can help battle a leading health problem in the U.S.
Anglo-Swedish company, AstraZeneca (AZN.L), gained FDA approval in the U.S. after Crestor was shown to reduce risks of stroke, heart attack and artery procedures (bypass or clearing) in people that suffer from high levels of CRP. The FDA put an age gap on the drug, stated men should be at least be 50 and women, at least 60.
According to AstraZeneca "The FDA approval was based on data from the landmark JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study which evaluated the impact of CRESTOR 20 mg on reducing major cardiovascular (CV) events in a previously unstudied population."
Furthering this comment, the FDA stated doctors "must interpret the results of the Jupiter trial with caution," because the findings "do not support the use of Crestor in all patients with elevated (CRP)." More affordable, generic versions of the drug being released by Pfizer could impede sales but the approval isn't slated until 2011.
"Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from Crestor therapy under this approved indication," AstraZeneca Chief Medical Officer Howard Hutchinson stated.
AstraZeneca produced global revenues of $32.8 billion in 2009 and stands as a "leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines."
Written by Amy Munday
Huliq.com
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