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Good afternoon, readers!
It was a big day in the Alzheimer’s treatment world as Biogen presented more detailed data on its controversial therapy aducanumab, which the drug giant hopes will become the first-ever Food and Drug Administration (FDA) approved medicine to actually treat the disease rather than just its symptoms. The company attempted to justify its unusual decision to revive the experimental drug it had initially left for dead in March and instead submit it for FDA approval.
By now, readers have heard plenty about the ups-and-downs, the various debates, and the hopes surrounding aducanumab. But the data presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego on Thursday raised more questions about the treatment. And aducanumab’s ultimate fate has far broader implications for the Alzheimer’s therapy space.
Critics continued to parse the design of a pair of late-stage clinical trials and Biogen’s shifting analysis of the associated dataset (the company claims more information had come in after aducanumab was initially abandoned earlier this year, and the protocol of the study had been changed to provide participants a higher dose of the drug). There’s still some confusion about why certain patients who received a lower dose experienced a decrease in their cognitive decline alongside some who received the higher dose.
The shareholder reaction to the CTAD data was decidedly mixed (Biogen stock tumbled at first, but then rebounded to close up by about 3.4% for the day). Baird analyst Brian Skorney, who penned a scathing note predicting aducanumab’s demise at the FDA earlier this week, continued to voice heavy skepticism about Biogen’s approach and the way the data has been rolled out.
But the bigger question is, how will all of this ultimately affect the so-called beta-amyloid theory, which posits that targeting the tell-tale amyloid plaque seen in Alzheimer’s patients (as aducanumab does) can help fight the disease?
The treatment’s initial demise prompted a parade of columns declaring it the final death knell of the amyloid hypothesis given a consistent string of failures for that approach.
An FDA green light for aducanumab could lead to a flood of companies willing to test the theory once more; a crash-and-burn could have the opposite effect.
But even here, there’s nuance to go around—including the prospect of combination therapies that target the plaque alongside other biological markers.
“Though there are still questions about the [aducanumab] data… if aducanamab is approved, it may be effective in combination with other therapies in development,” according to a statement from the Alzheimer’s Drug Discovery Foundation (ADDF) citing the organization’s chief scientific officer Howard Fillit.
Fillit goes on to say that beta-amyloid is just one part of the equation—and that effective Alzheimer’s treatment down the road may mimic the evolution of cancer drugs that use either personalized medicine or combination treatments to fight disease.
Read on for the day’s news.
FDA, NIH launch new mobile app to tackle infectious diseases. The FDA and the National Institutes of Health have launched a new mobile platform called CURE ID with the hopes of compiling data on the most effective and novel ways to combat infectious diseases. The service is meant for clinicians to pool information on the best drugs for various infections, and the populations in which they appear most effective. (MobiHealthNews)
Sage Therapeutics stock falls off a cliff over depression drug failure. Shares of Sage Therapeutics plummeted 60% (you read that correctly) after the company's experimental depression drug failed to achieve the main goal in a late-stage clinical trial. It's a big heel turn from earlier this year when the FDA approved Sage's Zulresso as the first-ever treatment for post-partum depression.
THE BIG PICTURE
The CVS-Aetna merger, one year out. I sat down with CVS Health CEO Larry Merlo earlier today to discuss what's happened in the year since CVS' massive $69 billion merger with insurer Aetna closed. I'll have a much more detailed account of our chat up tomorrow morning (keep your eyes peeled), but here are some teasers: Merlo touched on CVS' mission to meet patients where they live and become a far more comprehensive health care provider; how its use of Aetna's massive insured member dataset is helping drive that mission; and other pilot programs it's launched to achieve its lofty ambitions and expand its footprint.
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