Story at a glance
- An external committee will review the clinical trial data for Aduhelm.
- The drug was the first in about two decades to be approved to treat Alzheimer’s.
- Physicians and scientists have called Aduhelm’s data into question, along with its approval process.
The U.S. Food and Drug Administration (FDA) initiated an independent review of the previously approved drug intended to treat Alzheimer’s disease, agency director Janet Woodcock confirmed on Friday.
In light of recent controversy over the drug Aduhelm, manufactured by company Biogen, and its actual ability to help treat people diagnosed with the degenerative memory loss condition, the FDA will “fully cooperate” with pending recommendations from an independent committee.
The review will be conducted and overseen by the Center for Drug Evaluation and Research within the Department of Health and Human Services (HHS).
“I have tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research involved in the aducanumab review and their commitment to unbiased and science-based decision-making,” Woodcock wrote in a letter addressed to Acting HHS Inspector General Christi A. Grimm.
Given the ongoing interest and questions, today I requested that @OIGatHHS conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm. pic.twitter.com/iWJNxdZ5Cs
— Dr. Janet Woodcock (@DrWoodcockFDA) July 9, 2021
Since its approval from the FDA, health practitioners and scientists were quick to push back against its efficacy in successfully treating Alzhiemer’s cases based on a lack of clinical data evidence.
Doses of the drug would also be expensive, ringing in at $56,000 a year per patient. The U.S. Centers for Disease Control and Prevention (CDC) estimate that as of 2020 data, roughly 5.8 million Americans 65 years and older have been diagnosed with Alzheimer’s disease — a number projected to rise.
Prior to this external review, the FDA and Biogen augmented its usage recommendations, saying that Aduhelm should only be used in patients with mild Alzheimer’s dementia or other more mild cognitive impairments.
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“Aduhelm should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia,” the company wrote in a press release following the relabeling.
“Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval,” Alfred Sandrock Jr., the head of research and development at Biogen, said following the relabeling. “We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”
Other reports have documented meetings between senior Biogen staff, namely Sandrock, and FDA officials amid Aduhelm’s approval, adding criticism to the drug’s quick approval.
In response to the news of the review, Biogen’s stock fell on Friday.
“The trust of the American public, especially during these difficult times is of the utmost importance to the FDA – and we will continue to exercise transparency around our decision-making as allowed by the law,” Woodcock wrote.
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