Astra welcomes FDA vote on Crestor

16th Dec 2009 07:15

A US Food and Drug Administration (FDA) advisory committee has given a favourable verdict on the use of AstraZeneca’s anti-cholesterol drug Crestor.The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted by 12 to four, with one abstention, in favour of the judgement that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of Crestor in certain target groups. The ruling related to people who had no previous history of cardiovascular or cerebrovascular events or coronary heart disease (CHD) risk equivalent, covering the 50 and above age group for men and 60 and above for women. The review assessed data from the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) study, and is part of the regulatory process of Astra’s supplemental New Drug Application (sNDA) for Crestor.Howard Hutchinson, MD., Chief Medical Officer of AstraZeneca, said the advisory body’s deliberations would ‘help guide our ongoing dialogue with the FDA regarding our request for an indication that supports the use of CRESTOR for the prevention of cardiovascular disease in patients with an increased risk of experiencing cardiovascular events.’