Concerns With Alzheimer’s Drug Development Guidance

Biogen praises an FDA draft guidance on developing drugs to treat early Alzheimer’s disease and offers one comment on the diagnostic criteria for early Alzheimer’s and two comments on outcome measures. The company also provides line-by-line specific technical comments.

In its response, Public Citizen says that while it agrees with the need for research to develop new treatments and diagnostic tools for early Alzheiner’s, the draft raises three main areas of concern:

• the proposed definition of early Alzheimer’s and the reliance on biomarkers are both a diagnostic tool and a measure of benefit;
• the proposed criteria for the duration of clinical trials and the selection of clinical endpoints; and
• insufficient guidance for the development of drugs for early Alzheimer’s disease.

“We urge FDA to revise the final guidance to fully address these concerns,” the advocacy group says.