In Step Toward Approval, FDA Says New Alzheimer’s Drug Is Safe, Effective
The drug, called aducanumab, is administered intravenously once a month and aimed at slowing the disease in its early stages. The FDA will decide by early March whether to approve the drug.
The Washington Post:
Controversial Alzheimer’s Drug Gets Big Boost From FDA Staff
A drug that would be the first new treatment for Alzheimer’s disease in nearly two decades received a vote of confidence Wednesday from Food and Drug Administration clinical reviewers, who said “exceptionally persuasive” data showed the drug slowed cognitive decline caused by the devastating ailment. The FDA assessment also concluded the drug, called aducanumab, was safe. The document was released before an advisory committee meeting Friday during which outside experts will decide whether to recommend the agency approve the drug. (McGinley, 11/4)
Stat:
FDA Scientists Appear To Endorse Biogen's Alzheimer's Treatment
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. (Garde and Feuerstein, 11/4)
Boston Globe:
FDA Praise For Biogen’s Alzheimer’s Drug Sends It Stock Soaring By Nearly 44 Percent
If aducanumab is approved, it would be the first new Alzheimer’s medicine in nearly two decades and could become a blockbuster, meaning sales of at least $1 billion a year. An estimated 5.8 million Americans age 65 and older are living with Alzheimer’s, making it the sixth leading cause of death in the country, according to the Alzheimer’s Association. (Saltzmann, 11/4)
