FDA grants standard approval of Alzheimer’s drug, marking a new milestone for the disease that impacts millions of Americans. Trial data showed that the treatment slows the progression by 27% for patients in the earliest stages of Alzheimer’s.
The U.S. Food and Drug Administration on Thursday granted traditional approval to the Alzheimer’s drug lecanemab, known by the brand name Leqembi, after an accelerated approval was issued earlier this year.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.
Leqembi, from drugmakers Eisai and Biogen, is the first medication that’s been shown to slow the progression of Alzheimer’s disease, including declines in memory and thinking, by targeting the disease’s underlying biology.
“Today marks a breakthrough in the treatment of Alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable,” Biogen president and CEO Christopher A. Viehbacher said in a statement.
He said the company will be “working alongside Eisai with the goal of making [Leqembi] accessible to eligible patients as soon as possible.”
“This drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease,” Dr. Joy Snider, a neurologist at Washington University in St. Louis, told The Associated Press in January. “That might mean someone could have an extra six months to a year of being able to drive.”
This is amazing news for all of our residents suffering from Alzheimer’s Disease at all our Park Vista Locations.