Bioanalysis Zone

Researchers urge FDA to update drug approval standards for Alzheimer’s drugs


Research published by UsAgainstAlzheimer’s, has advised that the Food and Drug Administration (FDA) updates its current drug approval standard for Alzheimer’s drugs, which currently stipulate that new treatments have to demonstrate proven benefits in both cognition and function.

The authors, including George Vradenburg (Chairman and Founding Board Member of UsAgainstAlzheimer’s), have argued that proven benefit from a single therapeutic end point should be sufficient for FDA approval. This is suggested on the basis that any positive clinical improvement is still meaningful for patients as long as safety requirements are met.

It is argued that the requirement for a new Alzheimer’s drug to demonstrate effectiveness on two therapeutic end points has stifled progress in developing treatment for Alzheimer’s. It has been speculated that it may discourage further investment into new treatments for Alzheimer’s.

The paper also highlighted that despite the fact over 46 million people worldwide are currently living with Alzheimer’s, with this figure expected to almost triple by 2050 according the World Alzheimer Report 2015, it is a seriously under researched area. To demonstrate this point, the paper cites the difference in number of clinical trials for interventional Alzheimer’s drugs and similar oncology trials, which are 135 and 4976 respectively.

Although the authors admit that the lack of FDA approval for Alzheimer’s treatment (with the last FDA approval in 2003) is primarily due to the lack of effective drug candidates rather than obstacles enforced by the FDA, they do believe that clarification on the regulatory standards could have an impact on the potential number of Alzheimer’s treatments that reach the market.

It is hoped that if the FDA clarifies its position on drug approval standards for Alzheimer’s drugs, it could be the catalyst needed to increase investment for drug discovery and development in Alzheimer’s.

Sources: Us Against Alzheimer’s press release:;


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