FDA verdict on Biogen’s Alzheimer’s drug likely to be a ‘political decision,’ analyst says

Federal regulators may buckle to public and political pressure to approve Biogen‘s experimental Alzheimer’s drug, aducanumab, Jefferies’ Michael Yee told CNBC on Monday.

The Food and Drug Administration‘s verdict, expected in 2020, “will come down to a political decision, in our opinion,” said Yee, an analyst who covers the biotech sector, on “The Exchange.”

In March, Biogen pulled the plug on its Alzheimer’s drug and sent its stock tanking after an analysis from an independent audit revealed the experimental medicine was unlikely to work. However, shares of the Cambridge, Massachusetts-based company soared on Oct. 22 after the drugmaker shocked investors by announcing it was seeking regulatory approval for the drug.

Biogen’s drug targets a compound in the brain known as beta-amyloid, which is thought to play a role in the devastating disease by eroding synapses between nerve cells.

Biogen said that a new analysis of a larger dataset showed that aducanumab “reduced clinical decline in patients with early Alzheimer’s disease” and patients who received the drug “experienced significant benefits on measures of cognition and function such as memory, orientation, and language.”

There are currently no drugs approved that can reverse the mental decline from Alzheimer’s, which is the sixth leading cause of death in the U.S. The FDA has approved Alzheimer’s drugs aimed at helping symptoms, not actually reversing or slowing the disease itself. Biogen’s drug would be worth billions.

Yee said regulators will likely face pleas from friends and family members of Alzheimer’s patients asking for fast-track approval of the drug.

But Yee, like many other analysts, is also skeptical of Biogen’s new analysis of the drug.

“We’re more cautious on Biogen” and investors should be too, Yee said, claiming that Biogen’s data on its drug is “murky.”