US regulators have approved AstraZeneca Plc's (AZN,AZN.L) blockbuster cholesterol drug Crestor for use by old aged men and women, the Anglo-Swedish drug giant announced Monday. The Food and Drug Administration approved the drug for use in men aged 50 and above as well as women aged 60 and above, who have elevated C-reactive protein which could cause heart attack or stroke. Crestor has been approved to be administered when adequate trail of diet therapy to reduce elevated cholesterol fails.
AstraZeneca filed a supplemental New Drug Application or sNDA with the FDA in April 2009 to update the CRESTOR Prescribing Information with information about the impact of CRESTOR on reducing the risk of cardiovascular events in patients with an increased risk of experiencing cardiovascular events.
Recently, AstraZeneca said a new analysis of data from a major study of its blockbuster cholesterol drug Crestor found it reduced the risk of major heart problems or stroke in elderly patients. The company added that 20 milligram Crestor reduced major cardiovascular events by a dramatic 44% compared to a placebo in patients. It also said Crestor reduced risk of heart attack by 54% and stroke by 48%.
The study named JUPITER evaluated the impact of rosuvastatin 20mg on reducing major cardiovascular events and was conducted in 17,802 patients on middle and old-aged men and women. The data were presented in September at the European Society of Cardiology meeting in Barcelona, Spain, while the data on the study was first released in November 2008.
In a statement, chief medical officer, Howard Hutchinsone said, "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. This new indication adds to the significant body of evidence physicians use to evaluate CRESTOR as a treatment option."
Crestor is a member of the drug class of statins, used for the treatment of high cholesterol or dyslipidemia. Crestor reduces LDL cholesterol, total cholesterol and triglycerides, and raises HDL cholesterol or good cholesterol. However, Crestor is not approved to reduce cardiovascular morbidity and mortality. Crestor was initially developed by the Japanese pharmaceutical company Shionogi Co., Ltd., Osaka, Japan, and in-licensed to AstraZeneca in April 1998 to markets it as Crestor, and has now received regulatory approval in over 95 countries.
Crestor is available in tablet form of 5 mg, 10 mg, 20 mg, or 40 mg for oral administration. The tablets are pink, round or oval, biconvex, film-coated, and imprinted with "ZD4522" and tablet strength. It is noted that 97% of worldwide sales have been at or below the 20 mg dose.
In July 2009, the FDA granted an additional six-month period of market exclusivity to Crestor based on studies the company conducted in pediatric patients. The allowed six-month pediatric exclusivity period was then expended to July 8, 2016.
Pfizer's (PFE) cholesterol drug Lipitor, the top-selling prescription drug in the world, continues to be pressured by intense competition from Crestor and Merck & Co.'s (MRK) and Schering-Plough Corp.'s (SGP) Vytorin. In the recent second quarter, Crestor sales at AstraZeneca increased 23% to $1.129 billion, exceeding the $1 billion for the first time in a quarter.
AZN closed Monday's regular trading session at $43.13, up $0.08 or 0.19% on a volume of 1.33 million shares, lower than the three-month average volume of 1.44 million shares.
On the London Stock Exchange, AZN.L closed Monday's regular trading session at 2,780.00 pence, up 48.00 pence or 1.76% on a volume of 4.47 million shares, higher than the three-month average volume of 3.80 million shares.
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