By Christiana Sciaudone
Investing.com -- Biogen (NASDAQ:BIIB) received federal approval for its Alzheimer's drug. The stock is still halted from trading.
The U.S. Food and Drug Administration approved the controversial drug Monday, the first Alzheimer's treatment approved in 18 years, according to CNBC.
It's been a bumpy ride for the drug, with the FDA saying it appears to be effective, followed by an outside panel of agency advisers saying more data was needed, Bloomberg reported.
Aducanumab slows the progression of Alzheimer's in people with early signs of cognitive impairment. Alzheimer’s is the U.S.'s sixth leading cause of death.
Patient advocacy groups and some doctors have rallied for the drug's approval, but some experts have said there's a lack of compelling evidence that aducanumab can provide meaningful benefit, Reuters said.
Biogen has estimated that around 1.5 million Americans would be eligible for treatment with aducanumab, and could result in billions of dollars in revenue for the company, likely at a cost to Medicare.
The Institute for Clinical and Economic Review, a drug pricing research group, said in May there's "insufficient" evidence that aducanumab provides a net health benefit. Any drug proven to halt progression of Alzheimer’s-related dementia could be fairly priced at $50,000 to $70,000 per year, Reuters reported.
This is a developing story. Please check back for more information.