The US Food and Drug Administration (FDA) has released a second revision of its draft guidance for developing drugs intended to treat early Alzheimer’s disease.
The draft guidance, a revision of a previous draft guidance released by the agency in February 2018, is a document written for sponsors considering development of drugs for sporadic Alzheimer’s disease (AD) stages prior to a patient developing overt dementia. FDA appears to have reorganized the latest version of the draft guidance in acknowledgment of the changing landscape of AD drug development. (RELATED: Draft and Final FDA Guidances Detail Development of New Drugs for Neurological Disorders, Regulatory Focus 15 February 2018)
“This revision describes FDA’s current thinking regarding the use of biomarkers for the selection of participants with early stages of AD for enrollment in clinical trials, the selection of outcome measures for clinical trials in early AD, and the use of effects on characteristic pathophysiological changes of AD to support approval in these populations,” FDA wrote in a Federal Register notice…
