Drugmaker Seeks FDA Approval for First-Ever Alzheimer’s Drug

neurons over purple background with Biogen; drugmaker seeks FDA approval for first Alzheimer's drug

Pharmaceutical company Biogen has announced plans to seek FDA approval for the first-of-its-kind drug to treat Alzheimer’s disease. Seven months ago, Biogen suspended testing of the drug, aducanumab, because it was deemed ineffective in clinical trials. But now, the drugmaker is pointing to the same data to prove that it works. 

The approval of aducanumab

Aducanumab is an antibody therapy that targets amyloid beta, a protein that typically accumulates in the brain of a person with Alzheimer’s. If approved, this drug would be the first to reduce the clinical decline of Alzheimer’s. 

Biogen suspended testing for the drug in early 2019 due to lack of evidence that it improves symptoms of Alzheimer’s disease. In October, they pointed to the same evidence, stating that patients with mild cognitive impairment had their symptoms decline significantly after receiving high doses of the drug. 

According to a press statement by the company, these patients saw improvement in memory functions and understanding of their surroundings and language. They were also able to better perform daily tasks like cleaning, keeping up with personal finances, and traveling outside of the home by themselves.

Is it too good to be true?

Ted Whitford, a former Biogen employee who helped develop and test aducanumab before parting ways with the company, fears the drugmaker might be giving patients and caregivers false hope. Whitford’s father died of Alzheimer’s disease, so he had a personal stake in the drug’s development and success. 

“When I learned last week that Biogen had completed a retrospective analysis of the aducanumab data–the same data that seven months earlier the company had said justified stopping work on the drug–I thought of my father,” he wrote in a blog for StatNews

“I hope that Biogen made a mistake [when they suspended testing of the drug] back in March,” he continued. “But if it didn’t, and this is another example of the American public watching big pharma trying to spin bad data, then I can’t help but wonder if Biogen, and perhaps the industry, has lost its way.”

By suspending testing of the drug earlier this year, Biogen was out $18 billion, and shares fell nearly 30 percent. However, shares soared by 37 percent after last month’s reversal. 

Drugmakers Eli Lilly & Co., Pfizer Inc., and Johnson & Johnson abandoned attempts to treat amyloid buildup due to lack of efficacy and safety concerns. 

Biogen will begin the process to gain FDA approval for the drug in early 2020. 

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