US FDA conditionally approves controversial Alzheimer’s drugs

The United States’ Food and Drug Administration on Monday approved aduhelm, a drug used in the treatment of Alzheimer’s. This is the first drug to be approved for the disease in the US since 2003.

In a statement, the Food and Drug Administration said that the drug was approved using an accelerated approval pathway, which is given when the medicine for life-threatening or serious diseases has “meaningful therapeutic advantage” over the existing treatments.

As part of the accelerated approval approach, the drug will have to undergo a post-approval trial to verify if it has the expected clinical benefit. The agency can withdraw the approval to the drug if it fails to show the benefits in the trial.

Alzheimer’s is a progressive brain disorder that slowly destroys memory and thinking skills, and then eventually takes away the ability of the patient to do simple tasks, according to the health agency. Although the specific causes of the disease are not completely known, it is characterised by changes in the brain that leads to loss of neurons (nerve cells) and their connections. These changes affect a person’s ability to remember and think. Nearly 6 million, or 60 lakh, US residents and many others around the world have Alzheimer’s.

The drug…

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