FDA Faces Pressure Over Aduhelm Approval

A US congressional report released this week noted that the Food and Drug Administration (FDA) failed to heed its own advice when approving Aduhelm, a controversial treatment for Alzheimer’s disease. The report blamed the agency for overlooking key issues with data surrounding the drug’s actual clinical efficacy. In addition, it lambasted Biogen, the drug’s manufacturer, for the exorbitant price tag.

According to Edward Helmore, “Biogen, the report found, had set an “unjustifiably high” price by initially pricing Aduhelm at $56,000 (£46,438) a year. The pricing was established despite a lack of demonstrated clinical benefit in a broad patient population. The report said that the company’s own projections showed that it expected Aduhelm to be a burden to the government’s health insurer Medicare and costly to patients. After Biogen halved the cost, the federal insurer continued its coverage of the drug.”

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(Source: The Guardian, December 29^th, 2022)