Skip to Main Content
Contribute Try STAT+ Today

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!


What is it?

STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Create a display name to comment

This name will appear with your comment