Summary of the approval:
- The US drug authority has approved Aduhelm using an accelerated approval pathway.
- Known to be the first drug that can prevent the progression of Alzheimer's disease.
- A sigh of relief for over 50 million people who have dementia all over the world.
- The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need.
- The clinical trials for Aduhelm were the first to show that a reduction in amyloid plaques—a hallmark finding in the brain of patients with Alzheimer's—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.
- FDA requires the company to conduct a post-approval clinical trial to verify the drug's clinical benefit.
- If the drug does not work as intended, the FDA can remove it from the market.
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