FDA Proposes Change in Drug Approval Criteria for Alzheimer's Disease Medications


If new draft guidelines from the FDA take effect, drugs to treat Alzheimer's disease will only be required to demonstrate small improvements in patient cognition to qualify for approval.

If new draft guidelines from the FDA take effect, drugs to treat Alzheimer’s disease will only be required to demonstrate small improvements in patient cognition to qualify for approval.

The FDA has proposed a new policy that would free pharmaceutical companies from having to show their products improve daily function in patients at very early stages of Alzheimer’s disease. Instead, drugs could win FDA approval based on evidence that they help improve patient performance on memory and reasoning tests.

According to the proposed guideline revisions, patients at high risk of developing Alzheimer’s disease enrolled in drug trials could be evaluated with cognitive tests, whereas patients with mild symptoms of the condition could be tested with a combined test of function and cognition. For patients with no signs of functional impairment, it may even “be feasible to approve a drug through the FDA’s accelerated approval pathway,” suggested the authors of an editorial published in the March 13, 2013, edition of The New England Journal of Medicine.

Alzheimer’s experts have concluded that the best plan of action is to treat patients in the early stages of the disease, before there are obvious signs of neurodegeneration. Patients who appear normal but either have signs that amyloid plaques are accumulating in their brains or have a certain gene mutation that is associated with the development of Alzheimer’s would be the best candidates for preventive therapies released under the FDA’s newly relaxed guidelines.

Companies submitting a drug for approval for Alzheimer’s would also be required to conduct postmarketing studies to establish the clinical benefit of their therapy.

The loosening of the FDA’s regulatory framework for new drug applications will likely be welcomed by companies who have had difficulty proving the efficacy of their therapies for the treatment of Alzheimer’s. However, even under the new guidelines, these companies may find it challenging to measure minute changes in cognition, especially in patients with no obvious symptoms of Alzheimer’s, Sean Bohen, MD, senior vice president at Genentech, was quoted as saying in a New York Times article on the proposed guidelines.

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