New drug raises hopes of breakthrough on early Alzheimer’s

A drug company said yesterday it will seek federal approval for a medicine to treat early Alzheimer’s disease, a landmark step toward finding a treatment that can alter the course of the most common form of dementia.

Results of the new drug are seen as encouraging.

The announcement by Biogen was a surprise because the American company stopped two studies of the drug earlier this year, when partial results suggested it was not likely to be successful. It now says a new analysis of more results suggests that the drug helped to reduce a decline of thinking skills at the highest dose.

Biogen shares surged more than 26 per cent on Wall Street after the news.

The drug, called aducanumab, aims to help the body clear harmful plaques from the brain. Biogen is developing it with a Japanese company, Eisai.

Current drugs only temporarily ease symptoms of Alzheimer’s 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 that, in one study, those given a high dose showed 23 per cent less decline on one measure of thinking skills and smaller declines on other measures.

However, the company did not say how much difference it made in practical matters, such as whether patients were able to dress or feed themselves or live independently longer.

“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 consulted for Biogen on the studies. But filing for Food and Drug Administration approval “gives some hopes for patients and families that there may be disease-modifying therapies out there”, he said.

Biogen said more details, including on safety, would be given at a conference in December. The company said 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,” said Rebecca Edelmayer, of the Alzheimer’s Association, which had no role in the studies.