February 27, 2018
Authored and Edited by Nicholas J. Doyle; Shana K. Cyr, Ph.D.
On February 16, 2018, FDA issued draft guidance on Early Alzheimer’s Disease (AD): Developing Drugs for Treatment. This draft guidance revises the draft guidance related to treating AD from February 2013. FDA intends the new draft guidance to assist sponsors in the clinical development of drugs for AD that occurs before the onset of overt dementia.
FDA recommends basing eligibility for efficacy trials in AD at least in part on current consensus diagnostic criteria. According to FDA, important findings applicable to the categorization of AD along its continuum of progression include the presence of pathophysiological changes as measured by biomarkers, the presence or absence of detectable abnormalities on sensitive neuropsychological measures, and the presence or absence of functional impairment.
FDA identifies four categories as conceptually useful for the design and evaluation of clinical trials in different stages of AD: Stage 1 (characteristic pathophysiologic changes of AD but no evidence of clinical impact), Stage 2 (characteristic pathophysiologic changes of AD and subtle detectable abnormalities on sensitive neuropsychological measures, but no functional impairment), Stage 3 (characteristic pathophysiologic changes of AD, subtle or more apparent detectable abnormalities on sensitive neuropsychological measures, and mild but detectable functional impairment), and Stage 4 (overt dementia). FDA discusses clinical endpoints for early AD trials in patients with stage 1, 2, or 3.
FDA states that the use of a time-to-event survival analysis approach would be an acceptable primary efficacy measure in clinical trials in early AD, and that sponsors considering such an approach should discuss their plans with FDA early in development.
Readers are encouraged to read the draft guidance, also available on FDA’s website. Comments and suggestions regarding the draft guidance should be submitted to FDA by May 17, 2018.
Food and Drug Administration (FDA), FDA Guidance, drugs, new drug application (NDA), Biologic License Application (BLA)
Copyright © 2018 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
DISCLAIMER: Although we wish to hear from you, information exchanged in this blog cannot and does not create an attorney-client relationship. Please do not post any information that you consider to be personal or confidential. If you wish for Finnegan, Henderson, Farabow, Garrett & Dunner, LLP to consider representing you, in order to establish an attorney-client relationship you must first enter a written representation agreement with Finnegan. Contact us for additional information. One of our lawyers will be happy to discuss the possibility of representation with you. Additional disclaimer information.
Lecture
Patent Protection for Software-Related Inventions in Europe and the USA Training Course
June 5, 2024
Hybrid
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.