NEW YORK (CBSNewYork/AP) — In a shocking reversal, a company that had shelved a potential breakthrough medication for Alzheimer’s disease is now seeking federal approval for the treatment from the Food and Drug Administration.
Biogen Inc. said Tuesday it will seek approval for the medicine called aducanumab — a possibly landmark treatment that can alter the course of the most common form of dementia.
The announcement was a surprise because the drug company earlier this year stopped two studies of the drug when partial results suggested it was not likely to be successful. The company now says a new analysis of more results suggest that the drug helped reduce a decline of thinking skills at the highest dose.
Aducanumab aims to help the body clear harmful plaques from the brain. Cambridge, Massachusetts-based Biogen is developing it with a Japanese company, Eisai Co. Ltd.
According to the CDC, more than five million people in the United States and millions more worldwide have Alzheimer’s.
“The number of people living with the disease doubles every five years beyond age 65. This number is projected to nearly triple to 14 million people by 2060,” according to the CDC’s latest data.
Current drugs only temporarily ease symptoms and do not slow the loss of memory and thinking skills. Dozens of efforts to develop a drug to slow or reverse the course of the disease have failed.
The two studies tested aducanumab, given as monthly infusions, in more than 3,000 patients with mild cognitive impairment or early dementia due to Alzheimer’s. The company said Tuesday that in one study, those given a high dose showed 23 percent less decline on one measure of thinking skills and smaller declines on other measures.
“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s,” Michel Vounatsos, CEO of Biogen said in a statement. “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease.”
No details were given on how much that decline meant in absolute terms. For example, the company didn’t say how much difference it made in practical matters, like whether patients were able to dress or feed themselves or live independently longer, just that these skills overall declined less for those on the high dose of the drug.
“It’s a tricky question” whether the results are truly meaningful for patients until more details are known, said Dr. Ronald Petersen, a Mayo Clinic dementia specialist who has consulted for Biogen on the studies.
Filing for FDA approval however, “gives some hopes for patients and families that there may be disease-modifying therapies out there,” he said.
The company said more details would be given at a conference in December, including on safety. The company added that the most common side effects were inflammation in the brain, most of which did not cause symptoms or lasting problems, and headaches. The brain inflammation has been seen in other studies of Alzheimer’s medicines that target the brain plaques.
“We’re really encouraged by the information that they’ve provided today,” the largest benefit so far for any experimental medicine, said Rebecca Edelmayer, a scientist at the Alzheimer’s Association, which had no role in the studies.
News of the potential medical breakthrough sent Biogen’s shares soaring on Wall Street Tuesday — rising over 26 percent.
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