FDA Loosens Alzheimer's Drug Approval Process

The Food and Drug Administration (FDA) has announced that it is planning to adopt new standards for approving medications to treat Alzheimer's disease (AD) that could make it easier for pharmaceutical companies to get promising drugs to the steadily increasing number of people with the devastating illness. In an announcement in yesterday's online edition of the New England Journal of Medicine, Nicholas Kozauer, M.D., and Russell Katz, M.D., of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research pointed out that the focus of AD drug development has shifted to earlier stages of the disease, before overt dementia is evident, in part due to recent failures of once-promising products that have shown no benefit in late-stage disease when dementia has already appeared. "A leading theory," Kozauer and Katz explained, "posits that attempts at intervention may have been made too late in the progression of the disease, at a stage when neuronal damage had become too widespread."

However, improvement in function—a standard to which potential AD drugs have been held—"could lag substantially behind cognitive improvement mediated by pharmacological agents early in the course of the disease," they said. Thus the FDA is hoping to foster "innovative approaches to trial design and end-point selection." They said that "it might be feasible to approve a drug through the FDA's accelerated approval pathway on the basis of assessment of cognitive outcome alone."

"As the overall population is aging all over the world, the numbers of people with Alzheimer's disease will more than double in the next couple of decades, unless we can find ways to prevent it," APA President Dilip Jeste, M.D., told Psychiatric News. "I think this is an excellent decision on the part of the FDA. We should keep in mind though that the ultimate proof of the effectiveness of these drugs will lie in showing that the incidence of dementia in these patients is reduced significantly compared with the placebo group. Thus, longer term follow-up would be critical to assess the success of the new FDA proposal."

To read about recent attempts to develop drugs to treat AD, see Psychiatric News here and here.

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