Prognosis
Alzheimer’s Therapy Sparked Behind-Scenes FDA Clash on Approval
- Statisticians at the agency said evidence didn’t back approval
- Documents show internal dissent after public rift with experts
This article is for subscribers only.
Statisticians at the Food and Drug Administration who had a thorough look at the clinical-trial data didn’t support approval of Biogen Inc.’s Alzheimer’s therapy, internal documents released by the agency show.
The documents released on Tuesday show how top FDA officials weighed the concerns of their staff against the need of patients suffering from a serious fatal disease with no treatments that can halt its progression.