On Monday, something happened for the first time since the Bush administration. The U.S. Food and Drug Administration granted accelerated approval for Aduhelm, a drug that is meant to treat Alzheimer's Disease.
Granting accelerated approval for Aduhelm is an important breakthrough for marginalized communities. The FDA reports that "African Americans have a higher prevalence of Alzheimer’s disease and more severe consequences of the disease." Adding on, Alzheimer's Impact found that "African Americans are about two times more likely
than white Americans to have Alzheimer’s."
“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” Patrizia Cavazzoni of the FDA said.
“As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”
While Aduhelm could have a positive on Black communities across the nation, there are credible concerns regarding its accelerated approval. First, medical professionals are concerned that the drug was not tested properly before it was granted approval. Second, a year's worth of Aduhelm related treatment costs upwards of $50,000. While medical insurance providers will cover the majority of costs, a fraction of $56,000 can still be cost-prohibitive for many in need of the drug.
[This is a] dark day for [the] FDA. [They are] approving a drug on the basis of post-hoc analysis of a failed trial," Dr. Joseph Ross of Yale University tweeted.
“The most compelling argument for approval was the unmet need, but that cannot, or should not, trump regulatory standards. Unmet need is an important contextual factor, but it’s not an evidentiary threshold," epidemiologist Caleb Alexander added.
The back and forth regarding the approval of the drug rages on, but the goal remains the same. The American medical system needs to do more to support marginalized communities hit hard by Alzheimer's Disease.