US health experts this week will decide whether to recommend approval for Biogen Inc's Alzheimer's drug, which could become the first new treatment for the mind-wasting disease in decades even as serious questions persist over whether data show if it works.

A logo sign outside of a facility occupied by Biogen Inc., in Cambridge, Massachusetts on April 29, 2019. Photo: VCG

In a field littered with unrelenting failure, Biogen believes that in aducanumab the company has the first drug that can treat an underlying cause, and therefore slow progression, of Alzheimer's. But its path to approval has been anything but smooth or assured. Biogen abruptly ended clinical trials of aducanumab in 2019 after an early look at trial results showed it was not effective. In October 2019, the company shocked many Alzheimer's experts by reversing course, saying that a new analysis showed aducanumab could help patients with early-stage disease preserve their ability to function independently for longer. In July, Biogen filed for approval from the Food and Drug Administration.

Now the agency faces tremendous pressure to approve a treatment option for millions of Americans suffering from Alzheimer's and the millions more expected to face it in coming years. Patient advocates say the need for a new Alzheimer's treatment that could help people remain independent is heightened by the coronavirus pandemic, which has killed more than 229,000 people in the US.

"The pandemic came and it changed everything," said Russ Paulsen, chief operating officer at patient advocacy group UsAgainstAlzheimer's. "We need something to keep people out of nursing homes."