According to a report by federal watchdogs, approvals of medications from Biogen Inc. and Sarepta Therapeutics Inc. reveal problems with the procedure US drug regulators employ to expedite clearance for medications to address unmet needs.
Despite shaky evidence and reviewer differences, the US Food and Drug Administration swiftly approved Aduhelm from Biogen, Exondys 51 (eteplirsen) from Sarepta, and Makena from Covis Pharma, the Department of Health and Human Services’ Office of Inspector General reported Tuesday. The analysis discovered that in one instance, there was no documentation about important choices.
Disclaimer: This article is for informational purposes only and does not provide medical advice. Patients and families should discuss treatment options and clinical trials with their healthcare professionals.
