'It's a complete coin flip that will now be in the hands of the FDA,' says Jared Holz, a health-care strategist at Jefferies.
The Cambridge, Massachusetts-based company still faces an uphill battle with the federal regulator, however.
"It's a complete coin flip that will now be in the hands of the FDA," said Jared Holz, a health-care strategist at Jefferies, who put the chances of regulatory approval at 60%.The FDA will be under immense pressure from advocacy groups, patients and families living with the disease to approve the drug when Biogen submits it to regulators, likely in early 2020.
Aducanumab targets a "sticky" compound in the brain known as beta-amyloid, which is hypothesized to play a role in the devastating disease. More research is needed on the compound, and not all scientists are convinced that beta-amyloid is the primary cause of Alzheimer's. Many clinical trials targeting the compound have ended in failure.
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