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Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense

In addition to the United States, Biogen has requested regulators in Australia, Brazil, Canada, the European Union, Japan and Switzerland to evaluate the drug.

The U.S. approval is an important victory for a company that has been relying on Aduhelm to make up for stalled or declining income from its different merchandise. Competitors final year launched generic variations of Biogen’s a number of sclerosis drug, Tecfidera, inflicting the company to overlook out on lots of of thousands and thousands of {dollars} in income from what had been its top-selling product.

The approval “completely transforms” Biogen, stated Brian Skorney, an analyst at Robert W. Baird & Company, who’s projecting that the drug will generate $7.5 billion in income in 2025. “This changes it from a declining revenue company to a growth company,” he stated, and, in so doing, “opens up a bit of Pandora’s box” by way of pricing and reimbursement.

While solely sufferers with delicate cognitive decline had been enrolled within the medical trials, the F.D.A. permitted the drug for anybody with Alzheimer’s, a wider group of sufferers than many consultants had been anticipating.

Just how profitable the drug shall be for Biogen will rely on what number of sufferers it may well attain — and in what circumstances, and for how lengthy, insurers are prepared to pay for it.

Dr. Steve Miller, the chief medical officer at the insurer Cigna, stated on Monday that he anticipated his company and most of its friends would pay for the drug solely for sufferers with delicate cognitive signs and higher-than-normal ranges of the protein amyloid of their brains.

“There’s just no data that more advanced patients will benefit,” he stated.

Dr. Miller stated he was disenchanted that the F.D.A. had made so many sufferers eligible. “You’re leaving the tough decision-making about who should be covered to the individual payers,” he stated.