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Aduhelm’s Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH

 
• By Sarah Karlin-Smith

Pulling the controversial Alzheimer’s drug’s BLA should not exempt Biogen from fulfilling ClinicalTrials.gov reporting requirements for two key studies, even if the research gets terminated, former head of the NIH data repository tells the Pink Sheet.

puzzle in shape of human head with missing pieces in brain
Clinicaltrials.gov reporting requirements should help fill in some data gaps on Aduhelm despite end of commercialization. • Source: Shutterstock

Biogen, Inc.’s decision to discontinue commercialization and terminate its ongoing research with Alzheimer’s treatment Aduhelm does not appear to release the sponsor from data transparency requirements associated with the laws and regulations governing the US’s ClinicalTrials.gov data bank.

Key Takeaways

  • US government appears to have levers to ensure that Aduhelm’s post-market trials report results publicly – something critics of the now defunct drug believe is important given the controversy surrounding its accelerated approval and the data’s relevance to other drugs being marketed and studied in Alzheimer’s.

  • Skepticism remains as to whether NIH would follow through on its enforcement mechanisms

Critics of the US Food and Drug Administration’s decision to grant Aduhelm (aducanumab-avwa) accelerated approval are now further frustrated by the prospect that the abandonment of the drug by Biogen could mean the loss of critical transparency from the key clinical outcomes trials of the drug

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