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Health & Medicine
Pradeep Kumar

08/06/21 12:00 PM IST

Controversial Alzheimer’s drug approved

In news

The U.S.’s pharma regulator, the Food and Drug Administration (FDA) conditionally approved the use of an Alzheimer’s drug, called aducanumab, the first such approval since 2003.

Details
  • The drug, which goes by the brand name Aduhelm, has been granted ‘accelerated approval’, meaning it will need to verify expected clinical benefits in a new trial.
  • The drug’s approval had become controversial, with growing pressure from those impacted by the debilitating degenerative brain disease on one hand and opposition from many in the scientific community who were not convinced that the drug had demonstrated efficacy in trials, on the other.
  • The drug, developed by Biogen, a Cambridge (Massachusetts)-based company and Eisai Co., a Japanese company, was pulled out of two trials in 2019 after it was thought not to be working. 
Alzheimer
  • Alzheimer's is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer's disease accounts for 60-80% of dementia cases.
  • Alzheimer's is not a normal part of aging. The greatest known risk factor is increasing age, and the majority of people with Alzheimer's are 65 and older. But Alzheimer's is not just a disease of old age.
Source: The Hindu

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