Leading Experts call for Less Stringent Alzheimer’s Drug Approval Standards

WorldPharmaNews reported on May 12 that “Alzheimer’s experts call for changes in FDA drug approval standards”: “Leading Alzheimer’s disease researchers and a prominent patient advocate today published an analysis, “Single Endpoint for New Drug Approvals for Alzheimer’s Disease,” urging the Food and Drug Administration (FDA) to clarify and modernize its current approach for approving new treatments for Alzheimer’s disease.

The analysis, authored by George Vradenburg, UsAgainstAlzheimer’s Co-Founder and Chairman, and Drs. Howard Fillit, Dave Morgan, Marwan Sabbagh, Paul Aisen and Richard Mohs, recommends that the FDA approve new medicines that demonstrate a proven benefit on at least one therapeutic endpoint – either cognition or function. The current FDA standards require a new drug to show benefits on both proven endpoints, an unnecessarily challenging hurdle the authors say may be inhibiting investment in new Alzheimer’s treatments.

Alzheimer’s disease biopharmaceutical research is lagging well behind that of other diseases, despite the fact that Alzheimer’s diagnoses will triple in future decades and that there is no current means to prevent, treat or cure the disease. The analysis notes that in 2014-2015, there were only 135 ongoing interventional Alzheimer’s disease clinical trials compared to nearly 5,000 similar trials for oncology drugs” and here’s a link to the original paper as well as a link to contact us for help with your drug development project.