In addition to the United States, Biogen has commissioned regulators in Australia, Brazil, Canada, the European Union, Japan and Switzerland to review the drug.
US approval is a decisive victory for companies that have relied on Aduhelm to make up for stagnant or diminished revenue from other products. Competitors launched a generic version of Biogen’s multiple sclerosis drug Tecfidera last year, causing the company to miss hundreds of millions of dollars in revenue from its best-selling products to date.
The approval “will completely change” Biogen, said Brian Scorney, an analyst at Robert W. Baird & Company, who said the drug will generate $ 7.5 billion in revenue in 2025. “We expect it to be produced,” he said, “opening Pandora’s box a bit” in terms of pricing and redemption.
Although only patients with mild cognitive impairment were enrolled in clinical trials, the FDA approved the drug for patients with Alzheimer’s disease, a much wider patient group than many experts expected.
The benefits of this drug to Biogen depend on how many patients it is delivered to and under what circumstances and for how long the insurer is willing to pay for it.
Dr. Steve Miller, Chief Clinical Officer of insurer Cigna, said on Monday that his company and most of its peers would only take the drug for patients with mild dementia and higher than normal protein amyloid levels. He said he would pay for it. In their brains.
“There is no data that more advanced patients will benefit,” he said.
Dr. Miller said he was disappointed that the FDA had qualified a large number of patients. “We leave it up to individual payers to make strict decisions about who is eligible for compensation,” he said.
Alzheimer’s disease medicine is a treasure of Biogen and is most likely at the expense of taxpayers
Source link Alzheimer’s disease medicine is a treasure of Biogen and is most likely at the expense of taxpayers