From left to right: Amylyx Co-founders and Co-CEOs Josh Cohen and Justin Klee (Photo courtesy of Amylyx)
A biotechnology company expects to get a rare second chance to try to win the support of a key federal panel for an experimental treatment, in this case, a medicine intended to treat a devastating neurological condition, amyotrophic lateral sclerosis, commonly known as ALS.
Amylyx Pharmaceuticals Inc. on July 5 announced that it expects the Food and Drug Administration (FDA) to hold an advisory committee meeting on Sept. 7 about the company’s experimental ALS treatment. The Cambridge, Massachusetts-based company said it expects discussion at this meeting to focus on additional analyses of data from research done on the treatment or AMX0035. (AHCJ has created a tip sheet for covering FDA advisory committee meetings held about experimental medicines or new uses of approved drugs.
The FDA has a target date of Sept. 29 for deciding on whether to clear AMX0035. This deadline was extended from June 29 to allow more time for the FDA to review additional analyses of data, Amylyx said. The company suffered a setback in March when the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-4 to say that evidence gathered to date had not proven the treatment works. The FDA considers the recommendations of its advisory panels, but it is not bound by them.
In a recent commentary in JAMA Neurology, Elisa de Paula França Resende, M.D., of the University of California, San Francisco, and colleagues write about how social determinants of health affect demographic patterns of dementia in the United States. Noting that with an aging population, the prevalence of dementia will increase substantially, Resende and her co-authors write that of the social determinants affecting dementia risk, health and socioeconomics act more strongly than do race or cultural identifiers. I will add here that being female also is involved in dementia risk, as women are at greater risk for it than men. Continue reading
Photo: Alan Kotok via FlickrActor Alan Alda is among an estimated 10 million people worldwide living with Parkinson’s disease.
Parkinson’s disease (PD) can be a devastating diagnosis, but most people can lead full, active lives for many years thanks to medications that can control common symptoms, as well as surgical options, speech and physical therapy and lifestyle changes.
Actor Alan Alda, 82, recently revealed he had the condition during an appearance on CBS This Morning. He’s one of about 60,000 people in the U.S. diagnosed with PD each year. More than 10 million people worldwide are living with this progressive neurological disorder, according to the Parkinson’s Disease Foundation. There is no cure. Continue reading
Image courtesy of the National Institute on Aging/National Institutes of HealthBeta-amyloid plaques and tau in the brain
For the first time, scientists have found a connection between abnormalities in how the brain breaks down glucose and the severity of the signature amyloid plaques and tangles in the brain, as well as the onset of eventual outward symptoms of Alzheimer’s disease.
World experts in aging for the first time are recommending that everyone age 70 and older have routine brain health screenings.
At a recent conference of the International Association of Gerontology and Geriatrics, in St. Louis, a consensus panel examined the importance of early recognition of impaired cognitive health. They concluded that annual memory and reasoning ability evaluation by a physician or health provider is an important step toward enhancing brain health for aging populations throughout the world.