Biogen Inc has shown “exceptionally persuasive” evidence that its experimental drug for the disease is effective, US Food and Drug Administration staff said Wednesday.
November 4, 2020 Share on FacebookShare Share on TwitterTweet Share on WhatsAppShare
The remarks were released ahead of a meeting Friday of outside experts who will review and decide whether to recommend approval of aducanumab, an antibody designed to remove amyloid plaques from the brain (REUTERS)
Approval from the U.S. Food and Drug Administration (FDA) could come in March, making the drug, aducanumab , the first new treatment for the disease in decades and the first that appears to be capable of slowing the progression of the fatal and devastating disease that affects millions of people.
After FDA staff declared Wednesday that Biogen Inc has shown “exceptionally persuasive” evidence that its experimental drug for the disease is effective, shares in the biotech company and its partner Eisai Co Ltd rose 40%. Comments from agency staff also boosted the actions of other Alzheimer's drug developers, including a 15% increase in shares of Eli Lily and Co.
The remarks were released ahead of a meeting Friday of outside experts who will review and decide whether to recommend approval of aducanumab, an antibody designed to remove amyloid plaques from the brain.
“The briefing documents suggest a positive vote from the Advisory Committee, which bodes well for approval,” said Guggenheim analyst Yatin Suneja in a research note. Mizuho Securities analyst Salim Syed called it “almost the best case” for Biogen.
Approval from the US Food and Drug Administration (FDA) could come in March (Europa Press)
However, the arrival of the approval of this drug would not be the first advance against the disease that occurs this year. In July, a blood test developed by Swedish and American scientists studying Alzheimer's disease diagnosed the disease with as much precision as methods that are much more expensive or invasive, a significant step toward a long-term goal for patients, doctors and dementia researchers.
The test has the potential to make diagnosis simpler, more affordable, and widely available to all people. The key to it is that the test determined whether people with dementia had Alzheimer's rather than another condition. And it also identified signs of the fatal, degenerative disease 20 years before memory and thinking problems were expected in people with a genetic mutation that causes Alzheimer's disease, according to research published in JAMA and presented at the Association's International Conference. Alzheimer's.
” The test was 96% accurate in determining whether people with dementia had Alzheimer's rather than other neurodegenerative disorders , “ said Dr. Oskar Hansson, lead author of the study and professor of clinical memory research at Lund University in Sweden. That performance, in a group of nearly 700 people from Sweden, was similar to PET scans and spinal blows, and was better than MRIs and blood tests for amyloid, another form of tau, and a third type of neurological biomarker called neurofilament light chain.
With information from Reuters
I KEEP READING: