Canadian approval for Astra's Crestor
Products Directorate of Health Canada to market CRESTOR
(rosuvastatin) 10 to 40 mg, a new medicine for the management of
primary high cholesterol (primary hypercholesterolemia), familial
high cholesterol (familial hypercholesterolemia), and abnormal
lipid levels (mixed dyslipidemia).
AstraZeneca Canada has received approval from the Therapeutic Products Directorate of Health Canada to market CRESTOR (rosuvastatin) 10 to 40 mg, a new medicine for the management of primary high cholesterol (primary hypercholesterolemia), familial high cholesterol (familial hypercholesterolemia), and abnormal lipid levels (mixed dyslipidemia).
"This is a huge milestone for Canada. We will be the first major market in the world to launch Crestor," said Gerry McDole, president and CEO, AstraZeneca Canada. "This is great news for the 43 per cent of Canadians who have elevated cholesterol levels, a modifiable risk factor contributing to cardiovascular disease, the leading cause of death in Canada. With the efficacy we've seen in clinical studies, CRESTOR could make a real difference to these patients' lives."
McDole also pointed out that in the Federal Throne Speech and in Tuesday's Federal Budget Speech the government has indicated that it is committed to timely and efficient scientific reviews for new medicines. He added : "Our vision for Canada is to have the most innovative and high quality health care system in the world. We cannot afford to settle for a sick health care system that needs to be sustained - sustainability is not good enough."
"Because of improved efficacy and the ability to get more patients to target cholesterol levels, CRESTOR represents an additional value of up to $75 million (€46.2m) Canadian to federal and provincial governments over three years," concluded McDole.
The clinical development programme for CRESTOR currently involves over 15,000 patients, including Canadians, and a number of head-to-head comparative studies. Clinical trials appear to demonstrate that CRESTOR delivers consistently greater reductions in LDL-C (bad cholesterol) than the most currently prescribed statins: atorvastatin, simvastatin and pravastatin.