Signs point to FDA approval for Biogen’s experimental Alzheimer’s disease treatment, though there are skeptics - (Morningstar via NewsPoints Desk)

  • Some analysts remain skeptical about the effectiveness of Biogen and Eisai's experimental Alzheimer's disease therapy aducanumab, which is set to be discussed at an FDA advisory panel meeting on November 6, reported Morningstar.

  • RBC Capital Markets analyst Brian Abrahams, who said he found FDA staff briefing documents that were released this week, to be "surprisingly supportive" of the drug, noting that the agency has a "clear predilection for approving the agent."

  • However, after reading the FDA document this week, Raymond James analyst Steven Seedhouse said he is still not persuaded that the drug works.

  • "In fact, our conviction that the drug probably doesn't work is increased," he said, adding "we're not sure how else to put it: FDA could approve a drug that may not work. They just did with [Gilead Sciences' COVID-19 drug] remdesivir, so why not again?"

  • An aducanumab approval could mean up to $12 billion in peak sales for Biogen, according to a Goldman Sachs estimate cited this year in a pharmaceutical trade publication, and it would also mark the first success for an Alzheimer's treatment after a string of high-profile failures, such as Eli Lilly's solanezumab.

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