New Biogen Data Showed No Major Safety Issues for Its Alzheimer's Drug

By Deena Beasley and Julie Steenhuysen

December 06, 2019

SAN DIEGO/CHICAGO (Reuters) - Biogen Inc on Thursday presented new data on its experimental Alzheimer's drug aducanumab that did not reveal any new safety concerns as the U.S. biotech company made the case to researchers and investors about why it plans to seek U.S. approval after declaring the drug a failure in March.

Biogen stock was last up 3.6%.

Experts had been watching closely for any statistical abnormalities or excess safety issues that would affect how the drug is reviewed by the U.S. Food and Drug Administration (FDA), likely in the second half of 2020.

It has been at least 15 years since the FDA has reviewed an application for a new Alzheimer's treatment, and an agent that can slow progression of the mind-wasting disease is desperately needed.

Alzheimer's experts on a panel organized by the company, who had seen the data previously, expressed confidence that the complicated study did show that the drug was able to slow progression of the disease.

"All of the data suggests this is a disease modification. That means the impact of the treatment will continue to accrue with time," said Dr. Paul Aisen, an Alzheimer's expert from the University of Southern California.

Others, however, acknowledged that the affected sample size was small and the trials were cut short early. Only one of the two phase 3 trials showed a benefit.

Biogen's shares had been halted prior to the presentation at a Alzheimer's meeting, reopened lower, and then rose as investors tried to parse the meeting from the complicated study.

Biogen has partnered with Japan's Eisai Co Ltd to develop aducanumab as well as BAN2401, which works in a similar way.