In October, AstraZeneca said it was
delaying by a year
its application to regulatory agencies for the experimental diabetes drug Galida. The company didn't find any problems with Galida, but it decided to postpone the filing date until 2007 to allow for an extra year of follow-up clinical trials.
And in December, follow-up clinical trials of the lung cancer drug Iressa showed there was no statistically significant difference in survival rates between patients taking the drug and patients taking placebo. The FDA approved the drug in May 2003 under a special protocol, and the agency is reviewing the recent test results. Iressa could be removed from the market.
The Cerovive study involved 1,700 patients in 400 medical centers in 40 countries; half received the drug, and half received placebo. The measurement favorable to Cerovive is called a Modified Rankin Scale, which assesses disability after an acute ischemic stroke, which accounts for 85% of strokes. This is caused by the interruption of the blood supply to the brain, such as a blood clot.
The measurement that showed no difference between placebo and Cerovive was the National Institutes of Health Stroke Scale, which evaluates neurological impairment. The two other clinical trials for the treatment include an extension of the acute ischemic stroke study and a study of Cerovive's treatment of adults with acute intracerebral hemorrhage, or bleeding in the brain caused by a broken blood vessel.