The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” over FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).
Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.
The Alzheimer’s Association had backed the FDA approval, but many experts had concluded there was insufficient evidence to merit even conditional approval of the drug. Three members of an FDA advisory committee who had recommended against aducanumab’s approval recently resigned.
William B. Schultz, an attorney who served as a deputy commission for policy at FDA in the 1990s, said the Alzheimer’s drug approval could play a role in causing “a potential change in the standard for approving drugs that is the most significant change since Congress adopted the efficacy standard in 1962.”
In its letter, Public Citizen concluded there was an inappropriate level of collaboration between FDA and Biogen in their analysis of clinical trial data. In 2019, Biogen and its partner Eisai (OTCMKTS:ESALY) had decided to discontinue two Phase 3 trials for aducanumab known as EMERGE and ENGAGE. The company later determined that data from the trials warranted regulatory approval.
Public Citizen also took issue with the use of an unvalidated surrogate endpoint in the trial, which involved the reduction of amyloid-beta plaques. While such plaques are a hallmark of Alzheimer’s disease, there is mixed evidence for the so-called “amyloid hypothesis,” which assumes that such plaques result in clinical deterioration. Some older adults with normal cognitive function have such plaques.
Becerra has not made substantial remarks regarding the aducanumab approval, but told Politico that the FDA is “entitled to a great deal of deference and independence in the way that it acts,” and that “all of us are looking to hear just how the FDA operates based on the science.”
Filed Under: clinical trials, Drug Discovery, Neurological Disease