US FDA approves AstraZeneca's Crestor for new indication

Anglo-Swedish drug major AstraZeneca says that the US Food and Drug Administration has approved Crestor (rosuvastatin calcium) for use in children aged 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high low density lipoprotein cholesterol (the 'bad' cholesterol) and increased risk of early cardiovascular disease.

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 patients with HeFH will now be included in the Crestor Prescribing Information,' said Alex Gold, executive director of clinical development for the drug at 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,' he added.