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Review of Approval Process

The US Food and Drug Administration's controversial approval of Biogen's Alzheimer's disease drug is to be reviewed, Stat News reports.

Acting FDA Commissioner Janet Woodcock called on the Department for Health and Human Services' Office of the Inspector General last month to investigate interactions between FDA staff and Biogen, and the office now says it will be reviewing FDA's accelerated approval pathway.

The approval of aducanumab, Biogen's Aduhelm, was controversial. As Time magazine reported in 2019 Biogen sought approval for the drug after a re-analysis of data from one of its clinical trials suggested it might slow cognitive decline among some patients. But in late 2020, an FDA advisory panel determined there was not enough data indicating the drug worked, and its subsequent approval led to resignations among panel members. One member noted the approval was based on the drug's effect on amyloid in the brain, which the panel was unable to discuss. Stat News further reported previously that the agency worked unusually close with the company on approval and there may have been "off-the-books" meetings between the two.

The OIG says its investigation will include "reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes." The Washington Post notes that the OIG will not examine whether aducanumab is effective.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.