Alzheimer’s drugs are coming, risks and all
Researchers fought for decades to find something — anything — that could help slow the progression of Alzheimer’s disease. Now trials of two new drugs suggest they may do just that. The drugs work by removing a protein called amyloid that accumulates in the brains of Alzheimer’s patients and is thought to be toxic. And the federal Medicare program has indicated it will cover the drugs if they gain full US approval, as appears increasingly likely.
That’s the good news. The less-exciting news is the treatment effect is modest: Memory continues to decline in most people, just not as rapidly. Eisai’s Leqembi — on the market now with accelerated approval and under review for full approval — slowed the memory robbing disorder by 27% in a big trial last year. And in a final-stage trial of Eli Lilly’s donanemab, the experimental drug slowed the disease between 29% and 36% on the same scale compared to placebo, the company said earlier this month. Eli Lilly plans to apply for full US approval for donanemab this quarter.
The drugs have potential downsides. For one, the drugs must be infused by a health care provider. Patients also need to come in for MRI scans to detect signs of brain bleeding or swelling. Researchers are only beginning to understand that side-effect. While most cases are asymptomatic, some have led to hospitalization and death.
These side-effects raise the complicated question of for whom the drug is really worth it.
“It is going to be a very challenging decision for families,” says David Knopman, a neurologist at the Mayo Clinic. “I don’t know what I would do if it were me.”
After years of failure, the drugs are clearly an important scientific advance. And plenty of people take the drugs without issue. But the limitations of the first generation of disease-slowing agents mean drug companies still have a lot of work to do to identify future drugs that will more dramatically slow the disease with fewer complications.
In the meantime, “people need to understand the risk,” says Vanderbilt University Medical Center neurologist Matthew Schrag. “Some cases can have very significant symptoms.” — Robert Langreth
Researchers fought for decades to find something — anything — that could help slow the progression of Alzheimer’s disease. Now trials of two new drugs suggest they may do just that. The drugs work by removing a protein called amyloid that accumulates in the brains of Alzheimer’s patients and is thought to be toxic. And the federal Medicare program has indicated it will cover the drugs if they gain full US approval, as appears increasingly likely.
That’s the good news. The less-exciting news is the treatment effect is modest: Memory continues to decline in most people, just not as rapidly. Eisai’s Leqembi — on the market now with accelerated approval and under review for full approval — slowed the memory robbing disorder by 27% in a big trial last year. And in a final-stage trial of Eli Lilly’s donanemab, the experimental drug slowed the disease between 29% and 36% on the same scale compared to placebo, the company said earlier this month. Eli Lilly plans to apply for full US approval for donanemab this quarter.
The drugs have potential downsides. For one, the drugs must be infused by a health care provider. Patients also need to come in for MRI scans to detect signs of brain bleeding or swelling. Researchers are only beginning to understand that side-effect. While most cases are asymptomatic, some have led to hospitalization and death.
These side-effects raise the complicated question of for whom the drug is really worth it.
“It is going to be a very challenging decision for families,” says David Knopman, a neurologist at the Mayo Clinic. “I don’t know what I would do if it were me.”
After years of failure, the drugs are clearly an important scientific advance. And plenty of people take the drugs without issue. But the limitations of the first generation of disease-slowing agents mean drug companies still have a lot of work to do to identify future drugs that will more dramatically slow the disease with fewer complications.
In the meantime, “people need to understand the risk,” says Vanderbilt University Medical Center neurologist Matthew Schrag. “Some cases can have very significant symptoms.” — Robert Langreth