Granted approval. The FDA granted approval for the drug to be used but is requiring Biogen, the company producing it, to conduct a new clinical trial.
Significant doubts. The F.D.A. advisory committee, along with an independent think tank and several prominent experts — including some Alzheimer’s doctors who worked on the aducanumab clinical trials — said the evidence raised significant doubts about whether the drug is effective. [Ix4]
Patient advocacy groups had lobbied vigorously for approval. There is strong support from those personally affected by Alzheimer’s for the drug’s approval because there are no other promising medications for one diagnosed with Alzheimer’s at this time. The last time an Alzheimer’s drug received approval from the FDA was in 2003.
Expressed skepticism…for a post-market trial The FDA ruled that Biogen, the company behind the drug, must complete a Phase 4 trial even though the drug has already received approval. Post-market trials are incredibly difficult to perform and unlikely to suceed, however, as patients who can get the drug from a doctor are reluctant to take the chance of receiving a placebo in the trial. [Ix4]
Crux of the controversy The heart of the issue is that two Phase 3 trials for the drug produced results that contradicted each other. One showed the drug had benefit, the other showed that it had none.