"Now, she said, she is seeing “an outpouring of interest” from companies and investors eager to pursue a variety of strategies to tackle Alzheimer’s. “My experience from other diseases is that this will lift all boats,” she said. In a field that has often been in despair, she added, “there is now hope.”
Some other experts agree that getting Aduhelm across the finish line represents a pivotal moment for Alzheimer’s, even if the benefit to patients turns out to be small.
“I think the drug will clearly benefit some patients,” said Paul A. Newhouse, director of Vanderbilt’s Center for Cognitive Medicine and a colleague of Schrag’s. “And it will encourage companies, even small ones, that they actually can get an Alzheimer’s drug through the FDA.”
Just two weeks after the FDA cleared the drug, Eli Lilly announced it would seek accelerated approval for its anti-amyloid drug, called donanemab, later this year, based on a small trial that showed the treatment reduced amyloid plaques and slowed cognitive decline. That was a sharp change for the company, which earlier had said it would wait for the results of a large late-stage trial before seeking full FDA approval. Other companies, including Roche, also have amyloid-busting drugs in trials.
To critics of the Aduhelm approval, Lilly’s change of heart is Exhibit A that the FDA’s decision will spur drug companies to seek quicker approvals based on smaller studies and surrogate endpoints — rather than large clinical trials and concrete evidence that patients benefited.
“One of the consequences is that other companies will say, ‘If this is your new lower bar, we want our drugs approved on that basis,’ ” said Jason Karlawish, co-director of the Penn Memory Center at the University of Pennsylvania. “Companies are companies, I can’t fault them for doing what companies do, but we have now unleashed drugs that we are not sure what the benefits are, and that could have enormous consequences.”
Other experts remain highly skeptical. Some say amyloid beta may be a symptom, not the cause of dementia. Others say that while it probably is a factor, it may not be the best target for treating the disease.
“Even if amyloid does cause Alzheimer’s disease, it does not necessarily mean you can cure the disease by removing it,” Vanderbilt’s Schrag said. “If someone came to the emergency room with a stab wound, just removing the knife wouldn’t cure them either.”
Amid the debate, there appears to be agreement on one point: If Aduhelm delivers a clinical benefit, it is likely to be modest. Most experts say combination therapies will be needed to treat Alzheimer’s, just as they are used to treat cancer and HIV.
“Even the most ardent supporters of the amyloid hypothesis don’t think that treating amyloid will be sufficient to make a big impact in improving cognition for patients,” said Rabinovici of UCSF. “This idea of combination therapies is becoming more and more key to approaches to treating Alzheimer’s disease.”
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This is not the entire article. I posted what I believe to be the most salient parts.
Based on the comments of Jane Woodcock and others in the article, I think the FDA would throw out the red carpet for A2-73 if we get good results.
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