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FDA approves first new Alzheimer's disease drug in nearly 20 years
The US Food and Drug Administration on Monday approved the use of the experimental drug aducanumab for early phases of Alzheimer's disease, CNN reports.
The news outlet adds that this approval was granted despite an FDA advisory committee concluding last year that there is not enough evidence to support the effectiveness of the treatment.
The drug was developed for patients with mild cognitive impairment with the aim of slowing the progression of Alzheimer's disease.
The FDA has not approved a novel therapy for Alzheimer's disease since 2003.
Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, explained the FDA's reason for granting approval of the experimental drug, saying, "There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives."
Cavazzoni continued, "At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward."
She also noted that the FDA ultimately "concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweighed the risks of the therapy."
Now that accelerated approval has been granted, aducanumab will be studied through a series of "post-approval studies." These Phase 4 confirmatory trials will be carried out to verify that treatments have clinical benefit.
If the confirmatory trial does not confirm the drug's benefit, then the FDA could remove the drug from the market.
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