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Alzheimer’s experts call for FDA Alzheimer's drug changes

The posting,”... 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.”

Additionally, this was stated:

The authors wrote that a modernized FDA standard for Alzheimer's medications would reflect changes in the field and in treatment since the 1990s, and it would also align with draft guidance issued in 2013 for drug development for early Alzheimer's. Specifically for Alzheimer's, the authors argue, if a new drug improves memory but has less positive impact on a patient's daily functioning skills, the medication should still meet standards for FDA approval, because clinically meaningful improvements in cognition matter importantly to persons with Alzheimer's independent of functional improvement and vice-versa.

Irrespective of the degree of impact on secondary measures, the notion that the FDA would deny approval for a safe and well-tolerated drug candidate that achieves its primary endpoint of improving cognition in patients with Alzheimer's disease is almost unthinkable," the authors wrote.

The authors emphasized that the new standard is essential at a time in which recent clinical trial failures on Alzheimer's drugs have adversely affected investment in disease research. The FDA has not approved a novel Alzheimer's treatment since 2003, and the 5.5 million Americans with Alzheimer's and their caregivers are desperate for innovation.

https://www.eurekalert.org/pub_releases/2017-05/apa-aec051117.php