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The FDA decision was based on a supplemental New Drug Application submitted by AstraZeneca which included data from the PLUTO (Pediatric Lipid-redUction Trial of rOsuvastatin) study. PLUTO was designed to evaluate the efficacy and safety of CRESTOR in children ages 10-17 with HeFH.
"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," said Alex Gold, MD, Executive Director of Clinical Development for CRESTOR, AstraZeneca US. "While we believe it was important to investigate the use of CRESTOR in these patients, AstraZeneca does not plan to actively promote this indication."
In July, AstraZeneca announced the FDA had granted an additional six-month period of exclusivity to market CRESTOR(R) (rosuvastatin calcium) for its approved cholesterol and atherosclerosis indications until July 2016. The decision was based on the supplemental New Drug Application submitted by AstraZeneca.
The completion of the PLUTO study satisfied AstraZeneca's commitment to the FDA to conduct a study evaluating the impact of CRESTOR on this pediatric population.
About Heterozygous Familial Hypercholesterolemia
Heterozygous familial hypercholesterolemia affects 10 million people worldwide(1) and is most commonly caused by a defect in the LDL-C receptor gene that leads to elevated LDL-C levels. The American Academy of Pediatrics states that pharmacological intervention should be considered for children with LDL levels greater than 190 mg/dL.
About PLUTO
The PLUTO (Pediatric Lipid-redUction Trial of rOsuvastatin) study was a 12-week, double-blind, randomized multicenter, placebo-controlled study with a 40-week, open-label follow-up. The PLUTO study was designed to evaluate the efficacy and safety of CRESTOR in children ages 10-17 with heterozygous familial hypercholesterolemia (HeFH), a genetic disease characterized by high LDL cholesterol (the "bad" cholesterol) and early cardiovascular disease.
About CRESTOR (rosuvastatin calcium):
Studies have previously shown that CRESTOR, as an adjunct to diet in adult patients, significantly lowered LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.
CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also approved for pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trail of diet therapy. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to reduce cardiovascular morbidity and mortality.
CRESTOR has now received regulatory approval in over 95 countries. Nearly 17 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.
Important Safety Information:
CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothers.
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg).
CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age greater than or equal to 65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir.
Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended. CRESTOR should be used with caution in patients who consume substantial quantities of alcohol.
CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose.
In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).
Please see accompanying full Prescribing Information. If you have any questions concerning CRESTOR, please contact AstraZeneca at 1-800-237-8898. CRESTOR is a registered trademark of the AstraZeneca group of companies.
About AstraZeneca
AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business. For more information about AstraZeneca in the US or our AZ&Me(TM) Prescription Savings programs, please visit: www.astrazeneca-us.com.
(1) Marks D et al. Atherosclerosis 2003; 168: 1-14
SOURCE AstraZeneca
http://www.astrazeneca-us.com
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