“Based on the considerations above, the applicant has provided substantial evidence of effectiveness to support approval,” FDA staff said in a document reviewing the drug published on the agency’s website.
Biogen’s drug, Aducanumab targets, a “sticky” compound in the brain known as beta-amyloid, which is hypothesized to play a role in the devastating disease.
A panel of outside experts is expected to meet Friday to recommend the drug’s approval to the FDA."
"The FDA’s final decision on Biogen’s drug is expected by March."
"In a lengthy document released Wednesday, FDA staff appeared to endorse approving the treatment, which would become the first new Alzheimer’s therapy in nearly two decades. The commentary, which provides the first glimpse at how FDA scientists view the oft-debated treatment, comes ahead of a Friday meeting of outside advisers, who will issue a nonbinding vote on whether to recommend aducanumab’s approval."
"Biogen’s data from one large clinical trial were “robust and exceptionally persuasive,” FDA reviewers wrote, endorsing the drug’s effects on the cognition of Alzheimer’s patients. A second, nearly identical study did not show a significant benefit, but “upon closer review,” the FDA agreed with Biogen’s argument that the sum of all the data suggests aducanumab is helpful to patients."
That is good news. Let's hope it helps.
marylago said:That is good news. Let's hope it helps.
This is from the Washington Post:
"The medication is designed to treat patients in the earlier stages of disease. If it is ultimately cleared, it would be a major advance — the first drug approved to slow deterioration in brain function, not just to ease symptoms."
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