Story Highlights Johnson & Johnson, Eli Lilly also offer promising Alzheimer’s treatments
But sales for Biogen’s most advanced candidate, aducanumab, have fallen short of expectations
CVS Health, Harvard Medical School researchers have validated a way to prevent Alzheimer’s from beginning in a person at risk for the disease
An experimental drug from Biogen and Johnson & Johnson for Alzheimer’s is a failure and stands no chance of FDA approval, according to a preliminary analysis of clinical trial data released last week by Biogen and the drug’s French partner AbbVie.
The analysis is the latest setback for the drug, which Biogen had hoped would become the first approved treatment for people who have been diagnosed with Alzheimer’s.
The results represent a “real disappointment,” said Dr. Martin Pompadur, an Alzheimer’s researcher at Harvard Medical School and Massachusetts General Hospital who led the study. “For us and for the Alzheimer’s community, it’s somewhat shocking and disappointing.”
Pompadur’s analysis was part of a larger long-term study that has evaluated about 4,600 people with mild to moderate Alzheimer’s across five countries. After a median follow-up of about nine years, Pompadur and his team analyzed the drug’s effectiveness in preventing Alzheimer’s from progressing. The results reported last week showed no signs of increased brain plaque build-up, which is one of the chief symptoms of Alzheimer’s. The drug also didn’t appear to slow memory loss.
In other words, the results did not meet the most stringent standards set by the drug companies and the FDA to approve a drug.
“This is probably one of the most important trials ever run,” Pompadur said. “We knew there were huge challenges, and we thought they might be overcome. But in this very short follow-up period, we saw that was not the case.”
The study involved people who have mild to moderate Alzheimer’s, which generally starts with memory loss. In that population, the drugs approved by the FDA — known as anti-amyloid therapy (TARGT) — have been relatively effective, Pompadur said. And some physicians have proposed that anyone who’s 50 or older might be at risk for developing the disease, so they should have access to the drug.
The importance of knowing your risks
For most patients and doctors, knowing your risk factors is crucial, Pompadur said.
About 5 million Americans have Alzheimer’s and the disease is expected to cost the U.S. $259 billion this year, according to the Alzheimer’s Association. There is no cure.
“The biotech companies started this (and) they’re not going to give up,” Pompadur said. “And we haven’t seen a drug that can cure, slow or even slow progression of the disease. We’re more like a chess match than a pinball game.”
Alzheimer’s research may gain momentum
Failed research can galvanize drug companies to further develop treatments that have a better chance of effectiveness, said Todd Sherer, president and CEO of the Alzheimer’s Association.
“While the findings are disappointing, they do not diminish the work being done in Alzheimer’s research,” Sherer said. “Regardless of the outcome, significant advances continue to be made every day, expanding knowledge that could contribute to a world without Alzheimer’s.”
In 2012, Pompadur published an article in the New England Journal of Medicine that examined data from a study that used small electrocardiograms to detect the disease before symptoms begin. That research found that people with mild to moderate Alzheimer’s had abnormal electrical activity in their hearts, and that these electrical patterns appeared consistent with the process of plaque build-up in the brain.
Some experts now believe that doctors could be able to test for Alzheimer’s and monitor patients using an electrical measurement that could detect inflammation, said Dr. Ruth Ann Howlett, a Washington University researcher and director of the Alzheimer’s Disease Centers in Cairo. Howlett and other experts have been conducting testing in Egypt for several years.
“This information can not only help us identify the disease early enough to be effective in treatment, but it can also make a crucial difference in whether we get the optimal therapeutic response,” Howlett said.
By Adrienne Burton, CNN