For the first time in nearly two decades, the US FDA approved a new therapy for Alzheimer’s with Biogen’s aducanumab drug.
According to CNBC, “The FDA’s decision was highly anticipated as U.S. regulatory approval would make aducanumab the first drug approved to slow cognitive decline in people living with the disease and the first new medicine for Alzheimer’s in nearly two decades. The drug is also expected to generate billions of dollars in revenue for the company.”
All despite the controversy over mixed clinical trial results.
In fact, according to Fierce Pharma, “In a trial called Emerge, patients who got the highest dose of aducanumab had a 22% statistically significant improvement on a clinical dementia scale over placebo after 78 weeks on the treatment, the company said. Yet the same patient group in the ENGAGE study did worse than placebo patients on that same measure, as well as on a test of cognitive function.”
They added, “Physicians may be unsure who should get it and for how long, while payers may balk at its lofty price tag and erect barriers that could limit reimbursement, analysts warn.”
While the US approval is certainly exciting news, some still have their doubts. From here, we’ll have to see just how many physicians prescribe the treatment before judging success.
“This should not be approved, because substantial evidence of effectiveness hasn’t been shown,” said Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, as quoted by The New York Times. “There’s very little potential that this will address the needs of patients.”
At the moment, BIIB is pulling back from its morning high of $295.35 to $286.43.