Biogen Alzheimer’s Drug Approved

Biogen’s Alzheimer’s Drug Aduhelm Earns FDA Approval

A new treatment option for Alzheimer's is now available

John G. Baresky

Aduhelm is an advanced therapy that targets amyloid-beta plaque

Biogen’s new product is intended to reduce amyloid-beta plaque. Beta-amyloid proteins associated with Alzheimer’s are found in several different molecular forms which collect between neurons. It develops from the breakdown of a larger protein known as amyloid precursor protein.

FDA provides wide leeway for Aduhelm to be prescribed

The FDA did not place a limit on the length of time a patient can be treated with Aduhelm (which is administered as a monthly IV infusion) for Alzheimer’s nor did they specify a specific stage of the disease for which the drug can be used.

  • Stage 2: Very mild early changes that include basic forgetfulness
  • Stage 3: Mild but discernible decline
  • Stage 4: Moderate, distinct decline including confusion and memory loss
  • Stage 5: Moderately severe decline that reduces patient self-sufficiency
  • Stage 6: Severely declining patient capabilities
  • Stage 7: Very severe decline that includes physical dysfunction

Biogen clinical and commercial outlook

Founded in 1978 and based in Cambridge, Massachusetts, Biogen generated about $13.4 billion in annual sales in 2020. The wide FDA indication and sizable market for Aduhelm may lead it to have a quick uptake by prescribing clinicians across the nation.

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