Biogen Reverses Course, Asks FDA To Approve Failed Alzheimer’s Drug
Biogen, a United States drug manufacturer, has asked the Food and Drug Administration (FDA), to approve their Alzheimer’s drug, Aducanumab. Their request is highly unusual, as it’s the same drug they suspended testing just seven months ago because it was ineffective in Phase-2 clinical trials.
The Biogen announcement, shocked the scientific community and the stock market on Tuesday. Scientists — because the drug data showed a clear failure — and Wall Street- because investors lost billions of dollars. And, as well the drug maker’s stock lost billions in value.
Biogen: Why The Reversal?
Simply put, they claim that a new analysis justifies their request to the FDA for Aducanumab’s approval. Additional data collected from new trials shows that participants with mild cognitive impairment and given high doses — showed significant improvement.
Both the scientific community and investors reacted to this announcement with very guarded optimism. The reason? After 40 years of intense research and billions of dollars spent on research, there is still no drug cure for Alzheimer’s disease.
What is Aducanumab?
It is an antibody therapy that targets a protein — amyloid beta — that abnormally accumulates in the brains of people with Alzheimer’s disease.
Patients given higher doses of aducanumab , experienced better memory, sharper cognition, clear orientation to their surroundings, and clear language. Also, they could perform daily living activities, including handling their personal finances, doing household chores, and traveling by themselves outside the home.
Alzheimer’s disease, affects an estimated 6 million Americans. If approved, this drug becomes the first therapy to reduce the clinical decline of this fatal disease.
Obviously, Biogen understands the enormous risk it is taking in requesting this FDA review. And, so too, for investors. The only party going into this without risk are the Alzheimer’s patients. FDA approval brings them life and hope.
The new clinical trials under FDA guidance and review will start in early 2020. Until then, Biogen will offer aducanumab to eligible patients previously enrolled in clinical studies. This new data will also be reviewed by the FDA.
The wait begins.