by reneeweaver | February 10, 2022 9:31 am
I saw this in Alzheimer’s research news. I wondered if Eisai looks like a strong company. Robinhood[1] gives it 50% hold, 25% buy, 25%sell.
From the Field: Aducanumab Approved for Treatment of Alzheimer’s disease (AD)
On June 2021, the US Food and Drug Administration (FDA[2]) gave ‘accelerated approval’ for the anti-amyloid drug aducanumab, which is the first therapy drug to demonstrate that removing amyloid from the brain is reasonably likely to reduce cognitive and functional decline in people living with early Alzheimer’s. An amyloid is a protein plaque that builds in the brain and is believed to be associated with Alzheimer’s disease.
Although the decision of approving aducanumab has been controversial, the drug is now being reviewed by the Centers for Medical Services (CMS) with regards to its coverage by Medicare. The ‘accelerated approval’ pathway is available under federal law when a drug intended for a serious disease is expected to provide a meaningful advantage over available treatments. A drug may be approved under this pathway when it has shown it can improve a measure of a particular disease and when it is “reasonably likely” that this measure predicts clinical benefit. In the case of aducanumab, that measure, believed to be reasonably likely to predict clinical benefit, is brain amyloid. The drugmaker Eisai has announced that it plans to apply for accelerated approval of another anti-amyloid drug, lecanemab, that has shown clear results in its ability to reduce brain amyloid. In a study of 856 participants, lecanemab significantly reduced brain amyloid and a late-stage clinical trial of 1,795 participants called Clarity-AD is ongoing to determine if there is also a cognitive benefit associated with the drug. The AHEAD Study is another clinical trial of lecanemab being evaluated in persons who have elevated brain amyloid but no symptoms of dementia[3]. This study is based on the idea that earlier treatment of elevated brain amyloid provides the greatest likelihood of clinical benefit. We will keep you informed on these studies as results become available.
I have two shares of Biogen already. What are other people’s thoughts on both Biogen and Eisai?
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