Biogen Files With FDA for Approval of Alzheimer’s Therapy

Biogen Inc. said it had submitted an application seeking U.S. clearance for its controversial Alzheimer’s disease therapy aducanumab, which if approved would be the first medicine available to slow the memory-wasting disease.

Shares of Biogen jumped as much as 9.9% to $294.99 in New York trading. Biogen’s stock price has been closely tied to investors’ expectations for aducanumab over the past few years.

Biogen and its Japan-based partner Eisai Co. asked for a priority review from the U.S. Food and Drug Administration, the Cambridge, Massachusetts-based company said in a statement. The agency has two months to accept or reject the application, with an accelerated review putting the medication on a path for a final decision by March 2021.

The submission “finally begins the big journey of what will be a hotly debated FDA review,” said Michael Yee, a Jefferies analyst who projects a positive decision could propel Biogen to $500 a share or more, while a negative finding could send them as low as $175 per share. He sees a “50/50 or better” chance of approval.

Aducanumab, a so-called monoclonal antibody designed to target amyloid plaque in the brain, has been one of the most closely watched drugs in development for several years. Biogen at one point had halted research on it after getting disappointing results, only to revive the drug in a reversal that surprised many scientists and investors and raised the hopes of millions of patients and families.

That episode, along with questions about seemingly clashing clinical-trial data, has generated skepticism among some observers. Data presented in December at the Clinical Trials on Alzheimer’s Disease conference in San Diego showed conflicting findings, with one trial suggesting the drug could be the first-ever to slow the progression of Alzheimer’s. But a second, essentially identical trial showed no effect on the disease at all.

Stifel analyst Paul Matteis said he has been “skeptical on the clinical data package,” and considers the therapy to have only a 33% probability of success. Should Biogen be granted a priority review, however, that would suggest the FDA is leaning positively, he said.

Alzheimer’s is a progressive disease that most commonly arises in people over age 60. It robs patients of their memories and their minds, causing impaired speech and thought. More than 5 million Americans are living with the disease, according to the most recent data from the U.S. Centers for Disease Control and Prevention, and more than 14 million are expected to suffer from it by 2060.

With no medications currently available to slow the progression of the disease, demand for a therapy like aducanumab would be substantial. There are treatments that temporarily improve symptoms that generate billions of dollars in sales each year, even though they don’t offer long-lasting benefits.

“Alzheimer’s disease remains one of the greatest public health challenges of our time,” Biogen Chief Executive Officer Michel Vounatsos said in the statement. The application “is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease.”

The illness has been an elusive target for the pharmaceutical industry, which would make an approval of Biogen’s drug a significant milestone. Many drug companies have attempted to bring a therapy to market without success -- overall, there have been about 200 failed attempts to find a treatment.

Biogen had been expected to submit the aducanumab application earlier this year. But in April, executives told investors the company was delaying submission for U.S. approval to the third quarter after data-processing challenges, and numerous employees sickened with Covid-19 derailed its more ambitious timeline.

Aducanumab is intended to combat the amyloid plaque that fills the brains of patients, the primary hallmark of the disease and long-believed to be responsible for the mental decline that comes with it.

If approved, the drug is likely to be costly for the health-care system. In addition to the price of the medication itself, patients will need to go to their doctor’s office to have it infused and submit to regular imaging scans of their brains.

There are also potential side effects. More than 40% of people who took high doses developed brain swelling or small brain hemorrhages; most of the time those incidents were seen on brain scans and didn’t produce symptoms.

July 8, 2020

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