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Biogen Seeks FDA approval

Biogen Seeks FDA Approval for Alzheimer’s Drug Aducanumab

By Phil Gutis | July 8th, 2020

In another step toward what could be the first treatment for early stage Alzheimer’s, Biogen and Eisai today said they have completed an application to the FDA to seek approval for aducanumab, a controversial test drug that some believe has shown promise in slowing the disease.

Biogen said today’s submission is the first “filing for FDA approval of a treatment that addresses the clinical decline associated with the devastating condition.” The company said it is seeking priority review from the FDA, which, if granted, could see a final decision on the drug by March 2021. 

Biogen said that the application included more than 4,500 files and nearly 2.5 million pages. 

“Alzheimer’s disease remains one of the greatest public health challenges of our time,” Michael Vounatsos, Biogen chief executive officer, said in a news release. “It robs memories, independence and eventually the ability to perform basic tasks from the people we love.”

Haruo Naito, Eisai chief executive officer, called the FDA application an “important step” in fighting Alzheimer’s, one which, he added, “currently cannot be stopped, delayed or prevented.”

Aducanumab has had a rocky history. Early stage trials showed a great deal of success in clearing amyloid plaque from patient’s brains. Amyloid plaque is a hallmark of brains devastated by Alzheimer’s.

In the spring of 2019, however, Biogen and Eisai abruptly cancelled the trials, saying the drug had failed to pass a “futility analysis,” meaning that although the drug was successful in clearing amyloid it had not led to any significant slowing in the disease’s progression.

Last October, Biogen and Eisai reversed course, saying that late-arriving data had actually shown improvement for people living with mild cognitive impairment or very early Alzheimer’s. In December, at a packed conference in San Diego, Biogen said that patients who received aducanumab experienced significant slowing of decline on measures of cognition and functions such as memory, orientation and language.

Patients also experienced slowing of decline in activities of daily living including conducting personal finances, independently traveling out of the home, and performing household chores, such as cleaning, shopping and doing laundry.

“For many people living with the early stages of Alzheimer’s disease, maintaining independence for as long as possible is the ultimate goal,” said Stephen Salloway, director of the Butler Hospital Memory and Aging Program at Brown University. 

“If we can help slow the progression from one stage to the next,” Salloway said in the Biogen release, “this could preserve independence, which, in turn, could have truly meaningful benefits for people living with the disease and their loved ones.”

The Alzheimer’s Association also welcomed the FDA application. 

“For the first time in more than a decade, a new treatment for cognitive decline related to Alzheimer’s has been submitted to the FDA for review,” said Maria C. Carrillo, the Association’s chief medical officer.

In a statement, Carrillo looked toward the next battle if the drug wins approval. If that should happen, she said, “the top priority for the Alzheimer’s Association is to ensure access to the drug — as soon as possible — for everyone that could benefit.”

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