In Surprise Turnaround, Analysis Finds New Treatment May Work

Daily Herald (Arlington Heights, IL), November 17, 2019 | Go to article overview

In Surprise Turnaround, Analysis Finds New Treatment May Work


Byline: Tara Bahrampour The Washington Post

Seven months after clinical trials for a promising Alzheimer's drug were halted and the treatment was declared a failure, a new analysis suggests it was actually effective, and the company that makes it plans to move forward in securing federal approval.

The astonishing reversal on aducanumab, an antibody therapy that targets a protein called amyloid beta that builds up in the brain, comes after new data from the discontinued studies showed that at high doses the drug reduced cognitive decline in patients with early Alzheimer's.

"It could be a game-changer for the field," said Rebecca Edelmayer, director of scientific engagement at the Alzheimer's Association. "It could be one of the first disease-modifying therapies approved for Alzheimer's disease."

An estimated 5.7 million Americans 65 and older have Alzheimer's, and the Alzheimer's Association expects that number to mushroom to nearly 14 million by 2050 in the absence of new treatments. A handful of drugs approved by the Food and Drug Administration can alleviate some symptoms, but in the past 16 years no new drugs have been approved for the disease.

That may now change.

The drugmaker, Biogen, said patients receiving aducanumab experienced "significant benefits on measures of cognition and function such as memory, orientation and language." They also saw benefits in activities of daily living, including conducting personal finances, performing household chores and traveling independently outside the home.

Biogen said it plans to pursue regulatory approval for aducanumab in the United States and continue discussion on it with regulatory agencies internationally. The announcement sent the company's stock price soaring last month.

The company had stopped the trials in March after an independent monitoring board said the drug offered little hope of success, sending waves of disappointment through the scientific community after earlier trials had looked promising.

"The field was really pinning its hopes that aducanumab would be positive, would show results," said Ronald Petersen, director of the Mayo Clinic Alzheimer's disease Research Center and the Mayo Clinic Study of Aging, who consulted with Biogen on the drug but was not involved in the studies. …

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