Aducanumab (Aduhelm) gets FDA approval for treating Alzheimer’s

After many years to be exact after 18 years FDA approved a new drug for treatment of Alzheimer’s disease. This new drug is aducanumab (Aduhelm). Biogen is the manufacturer of aducanumab with brand name Aduhelm.

About alzheimer’s disease

Alzheimer’s disease is the most common type of dementia that is a medical term for memory loss. Alzheimer’s disease is the cause of dementia accounting for 60-80 percent cases of memory loss.

Human organs are made up of individual cells. Over the period cells of the brain die and it may cause reduced function and loss of memory. This is the pathology in Alzheimer’s disease. It causes scars and shrinkage of the size of the brain. Most of the patients of Alzheimer’s disease are more than 65 years old but it is not the disease because of old age as memory loss is not a feature of old age.

Not only brain cell death but also abnormal proteins called tau proteins get deposited in cells leading to formation of amyloid plaques in the brain.

Patients with Alzheimer’s disease will show following features:

  • Loss of memory
  • Difficulty in finding words while talking
  • Not able to communicate with others
  • Not ability to respond to environments
  • Suspicious nature with baseless suspicions on surrounding people.
  • Behavioural changes
  • Difficulty in walking

Aducanumab (Aduhelm)

Aducanumab is a monoclonal antibody that slows the disease process in Alzheimer’s disease. 

How does this medicine work?

Basically accumulation of abnormal tau proteins leading to formation of amyloid is the cause of Alzheimer’s disease. 

Adunacumab or Aduhelm is a monoclonal antibody against amyloid proteins. Adunacumab or Aduhelm reduces accumulation of amyloid protein in brain tissues. This slows down the disease process.

This medicine just slows down the disease process, it does not cure the disease. Additionally in Alzheimer’s disease there is cell death in the brain. Adunacumab slows down the process of cell death by reducing accumulation of amyloid but does not stop it.

What are side effects?

Aduhelm has following side effects:

  • Confusion
  • Disorientation
  • Fall
  • Mental deterioration
  • Headache
  • Loose motions
  • Amyloid related imaging abnormalities (ARIA): This is a side effect in which there is abnormality detected at sites of amyloid in neuroimaging. ARIA occurs after giving Aduhelm and is detected on neuroimaging as swelling and small hemorrhages. Clinically it has no or minimal symptoms. Some people may present with vision changes, headache and mental confusion.

To whom can Aduhelm or aducanumab be given?

Aduhelm or aducanumab can be given to those who are suffering from Alzheimer’s disease.

This drug was tested only in patients with mild disease or those with disease in initial stages. It has not been tested in those with moderate to severe disease with disabilities.

Biogen and Cigna also plan on entering a valued-based contract that will base payments for the medication based on how well a patient responds to it.

Cigna is likely to cover patient groups that are similar to those were tested in the studies. Before starting this drug, confirmatory tests like CSF examination or neuroimaging may be needed.

Manufacturer Biogen has estimated that 1.5 million people in the USA need Aduhelm.

When will Aduhelm be available in the market?

Biogen is expected to start shipping this medicine in 2 weeks in the USA.

What is the price of Aduhelm?

Currently Aduhelm is listed at a very costly price of 56000 USD. Those on this treatment will need a cost of 56000 USD per annum.

How is Aduhelm given?

Aduhelm is given as an intravenous injection with an interval between doses at least 4 weeks. Over 1 year or 52 weeks 14 to 17 doses may be given.

Why the controversy surrounding Aduhelm?

Currently the FDA approval process for Aduhelm is under criticism. FDA has given this drug approval for treatment for Alzheimer’s disease with its rapid approval method. Though enough studies are not available to prove its role, according to the FDA it is highly likely that Aduhelm will be effective in treating Alzheimer’s.

After this process of rapid approval a follow up study is required to prove the fact. Biogen is supposed to provide a follow up study and the FDA will monitor the effects of this drug. 

The approval process itself has created huge controversy and various discussions in the media that FDA supports pharma.

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