The U.S. Food and Drug Administration (FDA) on Monday, June 7, approved the drug aducanumab for the treatment of Alzheimer’s disease, which affects 6.2 million Americans.
Sudha Seshadri, MD, professor of neurology at UT Health San Antonio and director of the university’s Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases, issued the following statement:
“We are excited that a drug, aducanumab (Aduhelm, from Biogen), has been approved by the FDA for treatment of persons with early symptoms due to Alzheimer’s disease. This is the first new drug approved for Alzheimer’s in two decades.
“It should be noted that there are differing opinions about how useful this drug will prove in the long run. This FDA approval was under an ‘accelerated approval’ mechanism to make potentially valuable treatments available even while there is still some residual uncertainty regarding benefit. Studies of this drug showed clearly that it reduced the amount of amyloid plaque in the brain. Reducing the amyloid plaque may improve memory and thinking, but whereas one study suggested a small amount of benefit in slowing down the worsening of clinical symptoms, a second study showed no benefit. Hence the FDA has required that the company Biogen conduct Phase 4 trials to confirm the anticipated benefit. If the confirmatory trial does not verify the drug’s clinical benefit, FDA has procedures that could lead to removing the drug from the market.
“At the Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases, we are approaching this newly approved treatment with a proactive, thoughtful approach that will balance risk and benefit for each patient based on the latest science and the careful judgement of our expert clinicians. We believe it is best used for persons who are very similar to those included in the trials, that is, persons who have early Alzheimer’s disease symptoms and confirmed amyloid plaques in the brain, and are not at too high a risk of side effects such as swelling or small bleeds into the brain. We plan to very carefully monitor, both clinically and with brain MRI, for side effects and partner with patients’ primary care doctors or geriatricians. We also plan to carefully monitor the response of each person who takes the drug through Phase 4 post-marketing studies as required by the FDA.
“Although unfortunately many patients will not be suitable candidates for this drug, this approval will likely be the first of many and emphasizes the benefit of enrolling in clinical studies. We need volunteers, especially from Hispanic ancestry, to complete clinical studies of other promising drugs currently in trials. If you wish to volunteer for a clinical trial, please contact the Biggs Institute at (210) 567-8229.
“Here’s to the hope of effectively preventing or treating Alzheimer’s and other dementias within this decade.”
The University of Texas Health Science Center at San Antonio, also referred to as UT Health San Antonio, is one of the country’s leading health sciences universities and is designated as a Hispanic-Serving Institution by the U.S. Department of Education. With missions of teaching, research, patient care and community engagement, its schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have graduated more than 37,000 alumni who are leading change, advancing their fields, and renewing hope for patients and their families throughout South Texas and the world. To learn about the many ways “We make lives better®,” visit www.uthscsa.edu.
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