AstraZeneca, Britain's second-largest drug company, has won American approval for its cholesterol-lowering drug Crestor to treat hardening of the arteries.
The Food and Drug Administration approval means that the drug, which already has sales of more than $2 billion (£958 million) annually, can be marketed more widely as a treatment to slow the progression of atherosclerosis, or clogging of the arteries. This is an important step to help differentiate Crestor from other cholesterol-lowering competitors.
It means Crestor, which is already widely prescribed for high-risk patients in the US, is the first of the widely used statin family of choles-terol drugs to win approval to treat atherosclerosis.
Atherosclerosis occurs when there is a build-up of fatty deposits, forming areas called plaques, in the artery wall. These can cause the arteries to narrow, restricting the flow of blood to vital organs. They can also rupture, triggering a sudden, complete blockage of blood flow. This can cause a heart attack, or a stroke.
An AstraZeneca spokesman said that the approval was “significant” for Crestor. The company is relying on the drug to drive growth.
However, it received a setback earlier this week when research was published that showed patients at risk of heart failure who took the drug, alongside standard drugs for the condition, were just as likely to die as those on standard therapy alone.
Astra is also facing a generic challenge to key patents on the medicine. The drug maker has been running a major programme of clinical trials to try to prove its superiority to other similar statin drugs and this FDA approval could give Crestor an edge over other potent cholesterol-lowering drugs such as Lipitor from Pfizer and Vytorin sold by Schering-Plough and Merck.
AstraZeneca said that Lipitor did not have an FDA-approved indication for atherosclerosis on its label.
Ben Yeoh, analyst at Dresdner Kleinwort, said he felt “mildly positive” about the news. “This is differentiation in terms of wording which confirms the consequences of statin therapy. This is not hard clinical outcome data. It helps to explain how Crestor is impacting on the development of atherosclerosis,” he said.
However, he added that a 1994 Merck study was still the reference study for the medical community: “The 4S trial from Merck & Co, published in 1994, was the mortality study which drove the use of all statins and is still the reference for the medical community today.”
Joseph France, an analyst with Bank of America, said that winning approval “could help differentiate the agent and reverse the sharp slowdown in market share gains that we've seen over the past few months”.
AstraZeneca recently revealed that Crestor could come under direct competition from Canadian generic drug maker Cobalt Pharmaceuticals, which has filed with the FDA to sell cheaper copies of the drug. AstraZeneca said it would challenge the company's generic application.
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