#Biogen applies to market Alzheimer’s disease treatment in the US

Biogen has asked the feds to let it market a potentially groundbreaking treatment for Alzheimer’s disease in the US, the company said Wednesday.

The Massachusetts-based biotech firm asked the Food and Drug Administration for an expedited review of the drug known as aducanumab, which would be the first treatment to change the course of Alzheimer’s if it’s approved.

The submission 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,” Biogen CEO Michel Vounatsos said in a statement. “We are committed to driving progress for the Alzheimer’s disease community and look forward to the FDA’s review of our filing.”

Biogen’s stock price soared nearly 10 percent on the news Wednesday to a high of $294.99.

Biogen said its marketing application included data from a clinical trial showing the drug helped slow the decline of memory and the ability to perform household chores and other tasks in Alzheimer’s patients who received it. A second late-stage study did not meet its treatment goals, but Biogen said some data from that trial “are supportive of the outcome” in the successful study.

The FDA has up to 60 days to decide whether to accept Biogen’s application for a review, the company said in a joint statement with Japanese drugmaker Eisai. The firms have been working together on aducanumab since October 2017.

The firms have been working together since October 2017 on aducanumab, which targets a protein called amyloid beta that abnormally piles up in the brains of people with Alzheimer’s.

The companies shelved two late-stage trials of the drug in March 2019 after data indicated they were unlikely to succeed. But they changed their minds in October, saying they would seek approval for aducanumab in the US given that the trials showed signs that the drug is effective in higher doses over extended periods of time.

Biogen’s effort to revive aducanumab has “eroded trust in management and will ultimately fall short,” according to Bloomberg Intelligence analysts Marc Engelsgjerd and Sam Fazeli.

“Though we remain skeptical, approval in 2021 may be possible given the high unmet need,” Engelsgjerd and Fazeli said in a Wednesday commentary. “FDA acceptance of the filing by early September is an important milestone.”

With Post wires