FDA offers new guidance on developing drugs for Alzheimer’s disease

On February 7^th 2013, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease, before the onset of noticeable (overt) dementia.

The draft guidance titled, “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease¹,” explains the FDA’s current thinking about the way researchers can identify and select patients with early Alzheimer’s disease, or those who are at risk of developing the disease, for participation in clinical trials. The FDA claim that in recent years, the research community has tried to find ways to identify these patients using criteria that are based on biological indicators (biomarkers). Researchers have also tried to develop sensitive clinical measures that can detect subtle mental decline.

According to the FDA press release, Dr Katz is quoted as saying “This draft guidance is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public,”  “The FDA is committed to vigorously addressing Alzheimer’s disease and will work with industry to help develop new treatments in this early population as expeditiously as possible.”

The FDA is seeking public comment on the draft guidance for 60 days. Instructions on how to submit comments are included in a related Federal Register notice² issued February 7^th 2013. In finalising the guidance document, the agency will consider the information received from the public.

To see the full FDA press release, please follow this link