The Sustenance and Drug Administration’s call on whether to approve Biogen’s experimental Alzheimer’s drug, aducanumab, will be the “most noteworthy decision” the federal regulator will make in 2020, Bernstein analyst Ronny Gal said Friday.
When prayed if he thought the FDA would approve the drug, Gal said, “Yes.”
“[But] you’ve got to be cautious about this,” Gal, who covers the health-care industry, said on CNBC’s “Power Lunch.”
Healthfulness industry analysts say that the FDA will be under immense pressure from advocacy groups, patients and families actual with the disease to approve the drug when Biogen submits it to regulators, likely in early 2020.
Biogen’s drug butts a “sticky” compound in the brain known as beta-amyloid, which is hypothesized to play a role in the devastating disease.
The Alzheimer’s Linkage estimates 5.8 million Americans are living with the disease. There are currently no drugs approved by the FDA that can flip side 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 intended at helping symptoms, not actually reversing or slowing the disease itself. Approval of the drug would likely spark stir.
However, some analysts are skeptical of whether Biogen’s drug actually works after the company’s apparent turn-about on exploring FDA approval.
In March, Biogen pulled the plug on the Alzheimer’s drug after an analysis from an independent gathering revealed the medicine was unlikely to work. However, the company shocked investors in late October by announcing it was seeking regulatory acceptance for the drug after all.
To alleviate any concerns that Biogen’s results were a fluke, the FDA could ask the biotech firm to do an additional try-out before considering approval, some analysts say.
“The data is flawed; there’s a lot of questions,” Gal said in the interview Friday.
In spite of the skepticism, Gal expects Biogen will still triumph.
“I kind of think it will work and they will get leave,” he said.
Gal added that it appears the FDA has been more willing to approve some drugs even if it doesn’t “pettish every t and dot every i.”