The potential cost to Medicare of Biogen, Inc./Eisai Co., Ltd.’s pricey new drug for Alzheimer’s disease has prompted questions regarding the US Food and Drug Administration’s leadership and the wisdom of approving a treatment that could have widespread use but is supported by tenuous evidence of efficacy, according to Senate Finance Committee Chairman Ron Wyden, D-OR.
Aduhelm (aducanumab) was approved on 7 June under the agency’s accelerated pathway on the condition that the company will conduct...