Astra lowers doses to appease Crestor critics

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The Independent Online

Astrazeneca is considering manufacturing lower doses of its controversial cholesterol-reducing pill, Crestor, which was criticised last week by a US safety regulator.

Astrazeneca is considering manufacturing lower doses of its controversial cholesterol-reducing pill, Crestor, which was criticised last week by a US safety regulator.

The company is planning to start making a 2.5 milligram tablet for the Japanese market - half the 5mg dose which is the lowest available in other countries. And it is examining the quantities of drug it needs to produce in the light of calls for doctors to prescribe lower doses in the West.

AstraZeneca shares fell to a 20-month low of 2,087p yesterday as it fights to safeguard sales of Crestor despite coming under fire over the drug's safety. Last week, David Graham, a safety official at the Food & Drug Administration, the US medicines regulator, said Crestor could be dangerous and needed further study.

Investors are nervous that Crestor's share of the lucrative US market for cholesterol-lowering drugs, called statins, could sink from the current 8 per cent level as a result of the publicity given to Dr Graham's concerns.

Rivals, including Pfizer, whose statin Lipitor is the world's best-selling drug, have in some areas begun offering free introductory trials of products to patients switching from Crestor. It will be two weeks before prescribing data is available to show how the debacle has affected sales.

A massive advertising blitz by AstraZeneca in the US defending Crestor's safety was attacked by Public Citizen, the consumer campaign group which wants Crestor banned. The newspaper ads say the FDA has no concerns over Crestor's safety, since it said last week that Dr Graham did not represent its views. Public Citizen says the ads are misleading because the FDA has not yet ruled on its request that the drug be taken off the market. A decision is due any time.

In Europe, 10mg is the normal starting dose but the European Medicines Agency is studying whether all patients should commence on 5mg, following a referral by Britain which has adopted the more cautious starting dose. The Japanese approval, expected before the end of the year, would most likely set a starting dose of 5mg, with 2.5mg being made available.

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