AstraZeneca’s Crestor Approved (NYSE:AZN)

It was a good closing day for AstraZeneca as they announced that the Food and Drug Administration has approved Crestor (rosuvastatin calcium) for use in pediatric patients suffering from heterozygous familial hypercholesterolemia (HeFH). Soon after the announcement was made there was some upward movement in shares of AstraZeneca but by the end of the day the stocks were down again to some extent. The Crestor drug will be used when diet therapy would fail in order to reduce elevated cholesterol. The so called HeFH disease is a genetic disease which is normally characterized by bad cholesterol and increases the chances of early cardiavascular problems and diseases.

In July 2009, AstraZeneca had worked upon Crestor and had announced that FDA had granted them additional six-months for exclusive marketing of Crestor. However, AstraZeneca went ahead and tested Crestor’s efficacy and safety through PLUTO (Pediatric Lipid Reduction Trial of Rosuvastatin). The PLUTO study was a 12 week, double-blind, randomized multicenter, placebo-controlled study with a 40 week open-label follow up. The study evaulated the efficacy and safety of AstraZeneca’s Crestor in children within age group of 10-17 who suffered from HeFH. In their announcement AstraZeneca mentioned that currently there are 10 million people worldwide who suffer from this genetic disease and the approval of Crestor will help such patients to great extent.

Crestor is basically an adjunct to diet to reduce the elevated levels of bad cholesterol and to increase HDL-C in patients suffering from primary hyperlipidemia and mixed dyslipidemia. Crestor already has received a regulatory approval in over 95 countries with around 17 million patients worldwide using Crestor for their treatment. Now with the approval from the Food and Drug Administration, Crestor will be also be used for the treatment of pediatric patients suffering from HeFH to reduce cardiovascular mortality.