Skip to Main Content

WASHINGTON — The Food and Drug Administration fast-tracked Biogen’s divisive Alzheimer’s drug Aduhelm, but it’s not going to do the same for amyotrophic lateral sclerosis anytime soon — and ALS advocates are outraged.

The FDA approved Aduhelm on Monday under “accelerated approval,” a special pathway that lets the agency greenlight drugs based on so-called surrogate endpoints. That means drug makers can prove that tumors shrank or plaques in the brain disappeared, rather than demonstrating that the drug helps cure or treat a disease itself. The pathway had until now been used almost exclusively for cancer drugs, but FDA’s drug center chief Patrizia Cavazzoni told reporters Monday that she hopes it will be used more frequently for neurodegenerative diseases.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


Create a display name to comment

This name will appear with your comment