FDA advisory committee recommends approval of Crestor
The Endocrinologic and Metabolic Advisory Committee to the US FDA has voted unanimously to recommend approval for AstraZeneca's Crestor (rosuvastatin calcium) as an adjunct to diet for the treatment of various lipid disorders including hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia.
The Endocrinologic and Metabolic Advisory Committee to the US FDA has voted unanimously to recommend approval for AstraZeneca's Crestor (rosuvastatin calcium) as an adjunct to diet for the treatment of various lipid disorders including hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia.
The FDA will now review the committee's recommendation and make its final decision on granting marketing approval for the statin.
Crestor has been studied in more than 24,000 patients worldwide and is currently being studied in an extensive clinical outcomes programme known as GALAXY, which includes more than 19,000 patients from 23 countries.
According to AZ, the clinical development programme for Crestor is the largest pre-approval program ever submitted to evaluate the safety and efficacy of a new statin. More than 12,500 patients are included in the safety database with more than 4,000 patients exposed to the 40mg dose. The most commonly reported treatment-related adverse events were myalgia, abdominal pain, nausea and asthenia.
AstraZeneca licensed worldwide rights to Crestor from the Japanese pharmaceutical company Shionogi & Co. The statin was first approved in the Netherlands in 2002 and approval has recently been granted in 23 other countries. Launches have occurred in several countries, including Canada, the Netherlands and the UK.
'We believe that once approved, Crestor will provide patients who are untreated or not at their target cholesterol levels with an important new treatment option in the control of elevated cholesterol,' said Howard Hutchinson, vice president of clinical research, AstraZeneca.