Will Biogen's drug candidate against Alzheimer’s be approved by the FDA?
Market Rules
Alzheimer's disease is a form of progressive dementia that affects 10% of 65 years of age and older. It is caused by the formation of amyloid plaques, which accumulation deteriorates the function of the brain. To date (December 2020), drugs to treat the disease only slow its progression, but do not remove those plaques.
Biotech company Biogen's new drug to treat Alzheimer's - the so-called aducanumab - is based on an antibody that can bind to and clear away the toxic form of beta-amyloid. There have been a few trials evaluating aducanumab's effectiveness, but scientists have argued that said trials did not prove the drug has a substantial effect to justify its approval by the US Food and Drug Administration (FDA).
Even so, Biogen gathered important and new data to apply for approval. Now, the FDA board needs to give feedback by March 2021 stating whether aducanumab is or is not suitable for approval as a new drug.
If the FDA approves aducanumab for the treatment of Alzheimer's this market will be solved as "yes".