US regulators have approved AstraZeneca's blockbuster cholesterol drug Crestor for use by children, the Anglo-Swedish drug giant announced Friday.
The Food and Drug Administration approved the drug for use in pediatric patients aged 10-17 with heterozygous familial hypercholesterolemia, or HeFH, a genetic condition producing high levels of LDL, or bad cholesterol.
Crestor has been approved to be administered when adequate trail of diet therapy to reduce elevated cholesterol fails.
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.
In a statement, executive director of clinical development for Crestor, Alex Gold said, "AstraZeneca is committed to studying the impact of Crestor in various populations with a high unmet medical need, including pediatric and adolescent patients. Information about the effects of Crestor in pediatric patients with HeFH will now be included in the Crestor Prescribing Information. While we believe it was important to investigate the use of Crestor in these patients, AstraZeneca does not plan to actively promote this indication."
HeFH affects 10 million people worldwide and is characterized by elevated levels of LDL cholesterol or bad cholesterol, and increased risk of early cardiovascular disease. Higher levels of LDL is most commonly caused by a defect in the LDL-C receptor gene, and pharmacological intervention should be considered for children with LDL levels greater than 190 mg/dL.
The London, U.K.-based company noted that the FDA decision was based on a supplemental New Drug Application sNDA submitted by AstraZeneca which included data from the Pediatric Lipid-redUction Trial of rOsuvastatin or PLUTO study. The completion of the study satisfied AstraZeneca's commitment to the FDA to conduct a study evaluating the impact of Crestor for pediatric use.
The PLUTO study was designed to evaluate the efficacy and safety of Crestor in children ages 10-17 with HeFH. The PLUTO study was a 12-week, double-blind, randomized multicenter, placebo-controlled study with a 40-week, open-label follow-up.
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, which takes effect upon expiration of the patent, will extend the exclusivity of Crestor to July 8, 2016.
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 39% compared with a placebo in patients over 70 years old. It also said Crestor reduced risk of heart attack and stroke by 45% each.
The study named JUPITER evaluated the impact of rosuvastatin 20mg on reducing major cardiovascular events and was conducted in 5,695 patients aged 70 years or older. The data were presented last month at the European Society of Cardiology meeting in Barcelona, Spain, while the data on the study was first released in November.
In July, AstraZeneca reported a year-over-year increase profit for the second quarter. Quarterly revenue inched up, while on a constant currency basis increased 9% year over year. Core net profit rose to $2.36 billion or $1.64 per share from $1.82 billion or $1.25 per share in the prior-year quarter. Quarterly sales increased to $7.958 billion from $7.956 billion last year.
AstraZeneca is now scheduled to report financial results for the third quarter on October 29, 2009. Analysts currently expects the company to report earnings of $1.40 per share for the third quarter, on revenues of $7.87 billion.
In Friday's regular trading session, AZN is currently trading at $44.86, down $0.21 or 0.47% on a volume of 0.41 million shares. In the past 52-week period, the stock has been trading in a range of $29.96 to $47.61.
On the London Stock Exchange, AZN.L is trading in Friday's regular trading session at 2,740.00 pence, down 27.50 pence or 0.99% on a volume of 2.73 million shares. In the 52-week period, the stock has been trading in a range of 2,126.00 to 2,966.00 pence.
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