More on Biogen Inc. – Will They or Won’t They?
I recently blogged about Biogen Inc. and the drug in development that is said to be the first treatment that could show decline in people with Alzheimer’s disease.
Since I wrote about this in November, 2020, Biogen has continued working towards the coveted regulatory approval from the U.S. Food and Drug Administration (FDA).
Despite a panel of experts at the FDA voting against the drug in November, 2020, the FDA has extended the review period of the drug by three months. For reference, the panel voted “no” to three questions related to whether a single successful large trial of the drug was sufficient evidence of the drug’s effectiveness, given the clear failure of a second large study.
Although the FDA is not obligated to follow the recommendations of the panel, it usually does.
Notwithstanding the FDA’s history of following the panel’s recommendations, this extension raised some hopes that the drug may still be approved which reflected in an increase of Biogen’s shares by 8% premarket.
Obtaining regulatory approval would certainly be of benefit to the shareholders of Biogen. However, if the drug is actually effective, it would certainly change the lives of many people afflicted with Alzheimer’s today.
Stay tuned for more updates!
Thanks for reading.
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