Alzheimer’s Drug Will Be A Watershed Moment For The Agency I personally would be very happy with outcome % 3...
The decision could go one of three ways, says Brian Abrahams, co-head of biotechnology research at RBC Capital Markets. “Our take is 20% probability of full approval, 40% probability of complete rejection, 40% probability of some restricted or conditional approval,” he says. A conditional approval would mean that the FDA would only approve the drug for use in certain populations, like those over age 85 or with a very severe form of the disease.
Alzheimer’s is a degenerative, dignity-stripping brain disease that causes memory and judgement loss in 1 in 9 people over the age of 65 in the U.S. The number of Alzheimer’s patients is increasing; in 40 years it is estimated that 14 million people in the country will have the disease. Scientists don’t fully understand the cause of Alzheimer’s disease, though it is likely a combination of genetic, environmental and lifestyle factors. What is known is that the disease causes visible changes to the brain, including an abundance of amyloid protein clumps, called plaques, and tangles inside neurons that send signals in the brain. “The disease is devastating, not just to the individual but for the family,” says Harry Johns, the president and CEO of the Alzheimer’s Association.
https://www.google.ca/amp/s/www.forbes.com/sites/leahrosenbaum/2021/06/04/fdas-decision-on-biogen-alzheimers-drug-will-be-a-watershed-moment-for-the-agency---and-the-biotech-industry/amp/