The US Food and Drug Administration on Monday approved the use of the experimental drug aducanumab for early phases of Alzheimer's, a debilitating disease affecting 6.2 million Americans.
"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," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in Monday's announcement.
"Alzheimer's disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones." said Patrizia Cavazzoni adding that "FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient's bedside."
Currently available therapies only treat symptoms of the disease, while this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer's, according to Cavazzoni.
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