Biogen’s Alzheimer’s Drug Aduhelm Earns FDA Approval
A new treatment option for Alzheimer's is now available
The FDA has approved Biogen’s (NASDAQ: BIIB) Aduhelm (aducanumab) for the treatment of Alzheimer’s disease, giving patients and medical professionals a desperately needed treatment option of which there are very few. Biogen developed the drug in collaboration with Tokyo, Japan-based Eisai, Co. (OTCMKTS: ESALY).
It has been almost 20 years since the last new Alzheimer’s therapy was approved. There are approximately 6 million persons diagnosed with Alzheimer’s disease in the United States.
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.
When higher than normal levels of this naturally occurring protein accumulate they can disrupt the cognitive and physical activity of patients.
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.
Generally speaking, Alzheimer’s has 7 stages:
- Stage 1: Patient exhibits normal behavior
- 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
At this early point of its lifecycle, Aduhelm is anticipated to slow the progression of the disease’s symptoms. If it proves to stop and/or reverse the decline of patient symptoms, Aduhelm will be even more widely prescribed but this could take months or years to prove itself out.
While health systems, managed care plans and PBMs may set rules and plan coverage limits for their own members or patients, the broad approval by the FDA allows Biogen to initiate a generously wide market access strategy.
Aduhelm will have to provide measurable, meaningful results, however. If the product does not demonstrate a satisfactory level of performance and positive outcomes, the FDA could amend its indications or withdraw its approval.
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.
Should Aduhelm meet or exceed clinical and cost expectations, it will result in positive outcomes for patients, clinicians, payers and investors.
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