sunny.png
Thursday December 5th, 2019 5:37PM

Biogen reanalyzes studies, presses ahead on Alzheimer's drug

By The Associated Press
Related Articles
  Contact Editor

Biogen Inc. said Tuesday 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.

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.

The drug, called 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.

More than 5 million people in the United States and millions more worldwide have Alzheimer's. 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% less decline on one measure of thinking skills and smaller declines on other measures.

However, 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.

But filing for federal Food and Drug Administration approval "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 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," 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.

Biogen said it would offer aducanumab now to patients enrolled in these and earlier studies of it.

Biogen shares were up more than 26% to $281.87 Tuesday, but some on Wall Street remained skeptical.

Mizuho Securities USA analyst Salim Syed said he wants to know more about the FDA's involvement in Biogen's decision. He also said in a research note that it's still just a hypothesis that removing beta amyloid plaques can benefit Alzheimer's patients.

The company's announcement "does not guarantee approval and questions remain," he said.

___

AP Health Writer Tom Murphy in Indianapolis contributed reporting.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.

  • Associated Categories: Associated Press (AP), AP National News, AP Online National News, Top General short headlines, AP Health, AP Business, AP Business - Corporate News, AP Health - Senior Health
© Copyright 2019 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
US endorses tobacco pouches as less risky than cigarettes
Tobacco pouches win 1st FDA endorsement as less risky alternative to smoking
4:33PM ( 3 minutes ago )
Canada's Trudeau wins re-election but faces a divided nation
Canadian Prime Minister Justin Trudeau begins his second term facing an increasingly divided Parliament and country
4:25PM ( 11 minutes ago )
Ethiopia's Nobel-winning leader warns Egypt over dam
Ethiopia's Nobel-winning leader warns Egypt over dam: 'No force' can stop disputed project
4:24PM ( 11 minutes ago )
Associated Press (AP)
NYC, California sue Postal Service over smuggled cigarettes
New York City and California are suing the US Postal Service to stop tens of thousands of cigarette packages from being mailed from foreign countries to US residents
2:10PM ( 2 hours ago )
US stocks edge higher on company earnings; Biogen surges
Stocks edged higher in early trading following several positive earnings reports from US companies, holding the S&P 500 above 3,000 and within range of its all-time high set on July 26.
10:30AM ( 6 hours ago )
Thailand bans use of paraquat and other toxic farm chemicals
Thailand's government has agreed to ban the use of three farming chemicals widely regarded as dangerous to human health
9:19AM ( 7 hours ago )
AP Health
Protests, uncertainty over possible Morales win in Bolivia
International election monitors are expressing concern over Bolivia's presidential election process after an oddly delayed official quick count showed President Evo Morales near an outright first-round victory
3:54PM ( 41 minutes ago )
Autoworkers from closed plants fight new GM contract
Workers at closed GM plants oppose new contract deal, but few see much of a chance to win
3:51PM ( 44 minutes ago )
US stock indexes waver on mixed company earnings
The major U.S. stock indexes wavered between small gains and losses in late-afternoon trading Tuesday as investors weighed a mixed batch of earnings reports from McDonald's, Procter & Gamble and other big companies.
3:42PM ( 53 minutes ago )
AP Business
US stock indexes edged mostly higher on company earnings
Major U.S. stock indexes are edging mostly higher in afternoon trading as investors weigh a mixed batch of company earnings reports
2:13PM ( 2 hours ago )
For toymaker Hasbro, trade wars are no fun
The trade war hits Hasbro with toy season approaching, and price hikes may be on the way for customers
1:44PM ( 2 hours ago )
Demand for fast, online delivery drives UPS 3Q
UPS capitalizes on demand for fast online delivery, topping profit and revenue expectations in 3Q
1:16PM ( 3 hours ago )
AP Business - Corporate News
Trump cites his support for Medicare, slams Medicare for All
Trump accuses Democrats of an all-out attempt to “totally obliterate Medicare” and portrays himself as the program’s defender
4:27PM ( 2 weeks ago )
Trump touts support for Medicare, slams ‘Medicare for All’
Trump travels to Florida to tout support for Medicare, slam Democrats on their ‘Medicare for All’ plan
11:16AM ( 2 weeks ago )
Japan ups sales tax to 10% amid signs economy is weakening
Japan raises consumption tax to 10%, raising worries economy might sputter
4:14AM ( 3 weeks ago )
AP Health - Senior Health
Canada's Trudeau wins re-election but faces a divided nation
Canadian Prime Minister Justin Trudeau begins his second term facing an increasingly divided Parliament and country
4:25PM ( 11 minutes ago )
Ethiopia's Nobel-winning leader warns Egypt over dam
Ethiopia's Nobel-winning leader warns Egypt over dam: 'No force' can stop disputed project
4:24PM ( 11 minutes ago )
Trump finds no simple fix in Syria, other world hotspots
President Donald Trump's plan to reverse American involvement in "endless wars" has run up against a difficult truth: When it comes to national security, rarely can a simple solution solve a complex problem
4:21PM ( 14 minutes ago )
Diplomat provides House with 'disturbing' account on Ukraine
A diplomat who has sharply questioned President Donald Trump's policy on Ukraine is providing lawmakers with a detailed account of events at the center of the impeachment probe
4:20PM ( 16 minutes ago )
2 students charged with slur at University of Connecticut
Two University of Connecticut students have been charged with shouting a racial slur on campus in an episode that was caught on video and has led to protests
4:12PM ( 24 minutes ago )