FDA Committee Votes Strongly Against Biogen's Alzheimer's Disease Drug
After a long day of the Food and Drug Administration and Biogen (NASDAQ: BIIB) arguing that Biogen's Alzheimer's disease drug, aducanumab, should be approved, the FDA's committee of outside experts pushed back and voted strongly against the drug.
The FDA didn't directly ask if aducanumab should be approved but instead focused on whether the single positive pivotal clinical trial was enough to gain approval. A second pivotal study failed to show an effect, and there were issues with the positive study because Biogen stopped the study early when it appeared aducanumab wasn't working. After a closer look at the data, Biogen concluded that the higher dose of the drug was helping patients, and the leadership at the FDA seemed convinced as well.
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Source Fool.com
