(Natural News) The Food and Drug Administration (FDA) drew criticisms after granting Alzheimer’s disease drug Aduhelm a conditional approval. It allows the drug scientifically known as aducanumab to be prescribed and used while its maker Biogen conducts a post-marketing, phase 4 confirmatory study that could take years to complete.
Aduhelm is the first Alzheimer’s medication approved by the FDA since 2003.
According to the influential Institute for Clinical and Economic Review (ICER), the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Aduhelm.
ICER questions Aduhelm’s effectiveness
The FDA, which announced the approval on June 7, said that the drug was the first to treat the underlying mechanism in Alzheimer’s. But ICER didn’t see it that way.
ICER argued that Aduhelm was effectively approved on the strength of a biomarker – removing amyloid from the brain – rather than clinical outcomes, which is puzzling as other drugs have been shown to remove amyloid from the brain yet failed to help patients.
In a statement, ICER said the view of many experts was that current evidence is not enough to support the use of Aduhelm in Alzheimer’s patients, and the FDA had “moved the goalposts” by not holding Biogen’s drug to the standards of other therapies.
“The avenue forward has seemed clear. Another study would be needed to reduce the substantial uncertainty about the drug’s effectiveness, a requirement of even greater priority because of the drug’s common and potentially serious side effects,” said the ICER, which deliberates on the cost-effectiveness of new medicines.
ICER pointed to brain swelling and potential bleeding seen in approximately 30 percent of patients treated with Aduhelm. (Related: Alzheimer’s breakthrough: scientists discover omega-3s override the bad gene causing Alzheimer’s.)