United States has approved the first new treatment for Alzheimer’s disease.
Gatekeepers News reports that the U.S Food and Drug Administration (FDA) on Monday authorised aducanumab for the early phases of Alzheimer’s disease, the first in nearly 20 years.
Aducanumab is the only drug approved by the FDA to treat patients with mild cognitive impairment, not severe dementia, and intended to slow the progression of Alzheimer’s disease, not just ease symptoms.
The FDA’s approval of the drug is however controversial due to a warning from its advisory committee last year, that there is no enough evidence to support the effectiveness of the treatment.
Gatekeepers News reports that Dr. Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, during Monday’s announcement, said: “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.
“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 said, noting that the FDA ultimately decided to use accelerated approval and “concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”
She said “FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside.”
Aducanumab is developed by the pharmaceutical company Biogen and its Japanese partner Eisai. The drug was developed for patients with mild cognitive impairment, not severe dementia.