The never ending Biogen Alzheimer’s drug saga delivers yet another twist

July 8, 2021, 11:09 PM UTC

Happy Thursday, readers.

First off, I have a request: We’re looking for nominations for Fortune‘s latest 40 Under 40 list, our annual roundup of the top business, government, cultural, and other up-and-coming stars beneath the age of 40. If you happen to have any suggestions for those who fit the bill in the health care space, please submit your suggestions here. And do it soon because the deadline for nominations is July 19!

On to the week’s news. And today in particular was a doozy for the biopharma sector. The dramatic show stealer is, yet again, Biogen and its highly-scrutinized Alzheimer’s medication Aduhelm. And in the latest twist, the biotech giant is voluntarily agreeing to a so-called “label change” for who should be prescribed this pioneering medication that would actually reduce its market reach.

Now, why might a company go along with that? It’s still a little fuzzy whether or not the Food and Drug Administration (FDA) itself initiated the process or if it was at the behest of Biogen, though the end result remains the same: the FDA originally granted a widespread approval to Aduhelm, also called aducanumab, for Alzheimer’s disease patients in the U.S. despite the heavy disapproval of its own independent advisers, and now Biogen, in conjunction with the regulator, is pulling back on that blanket language and recommending the drug be focused on those with mild Alzheimer’s disease be the main targets for the therapy.

Biogen says the decision was meant to boost confidence in its product by prioritizing the patient population which made up its clinical studies leading to aducanumab’s controversial approval. That may be the case. But there’s also been a political firestorm brewing around the FDA’s relationship with the biopharma industry, including what some critics such as California’s Rep. Katie Porter have called an inappropriately cozy dynamic between the regulator and those it regulates. The label change could serve as an olive branch of sorts to the fiercest Aduhelm skeptics.

What it means for the drug’s future is far from clear. Investors certainly paid no mind on Thursday, with Biogen’s stock price rising 3.9% in daily trading despite the announcement. That could be a signal that they believe the move was just enough to take some heat off the company and the FDA while still giving the drug giant the chance to reap billions in annual revenues given the size of the Alzheimer’s treatment market and Aduhelm’s $56,000 list price tag.

A more open question is whether physicians’ concerns will be quelled. A recent Medscape survey found that nearly 90% of doctors and neurologists disagreed or strongly disagreed with the FDA’s approval decision since there’s still scant evidence that the drug is effective in slowing down mental decline in these patients. Many in the poll said they wouldn’t even prescribe Aduhelm to patients without more concrete information. And that could make for an awkward medical dynamic between care providers and patients’ families who are seeking out just a bit of therapeutic hope in a space that’s traditionally been littered with failure.

Read on for the day’s news, and see you again next Thursday. And once again, send over your 40 Under 40 nominations here.

Sy Mukherjee


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