'New era of treating Alzheimer's': Wisconsin doctors, researchers celebrate FDA approval of new drug
MILWAUKEE (CBS 58) -- A groundbreaking new Alzheimer's drug is exciting doctors and researchers across the United States.
The U.S. Food and Drug Administration (FDA) granted accelerated approval of a new medication called Lecanemab or Leqembi, which targets the fundamental pathology of Alzheimer's Disease, according to a press release.
Alzheimer's Disease is an irreversible, progressive brain disorder that destroys memory and thinking skills. It affects more than 6.5 million Americans.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”
Dr. Cynthia Carlsson, Professor of Medicine at the University of Wisconsin-Madison, said Leqembi targets deposits of proteins in the brain called amyloid. Amyloid is believed to contribute to the symptoms of Alzheimer's Disease.
"What was impressive about this study is that it improved the amyloid levels in the brain, lowered those. It improved their cognition, improved their function, improved their quality of life, all of these things we really care about, as well as, what the brain looks like," Carlsson said.
Carlsson told CBS 58 the drug is primarily given to people with mild Alzheimer's symptoms intravenously every two weeks.
She said side effects can include increased risk of micro bleeds and swelling in the brain.
"The results from the clarity study showed pretty vigorous responses across all of these outcome measures, which we hadn't seen for a therapy like this before," Carlsson said.
Carlsson is leading a prevention study with Leqembi at UW-Madison.
"Using that exact same medicine but in people that are, don't have memory symptoms yet, but they have a special scan that shows that they do have amyloid build-up in their brain. So, way before they get memory loss," Carlsson said.
Leqembi went through the FDA's accelerated approval pathway. This happens for serious conditions where there is an unmet medical need and a drug is shown to have a clinical benefit to patients, according to a press release.
Carlsson said there are other drugs on the market, but this is the first in over 20 years to spark good cause for hope.
"We're in a really new era of treating Alzheimer's," Carlsson said.
The Alzheimer's Association is celebrating the FDA's approval.
Breaking: FDA grants accelerated approval of Leqembi (lecanemab) for treatment of the early stages of Alzheimer’s with confirmation of amyloid beta. This is a milestone achievement for those eligible for treatment, their families & the research community. https://t.co/HuGINgcyUh
— Alzheimer's Association (@alzassociation) January 6, 2023
"It gives us a ton of hope," Wisconsin Alzheimer's Association Research Champion Tim Harrington said. "It can give them a better quality of life for a much longer period of time."
Alzheimer's Association President and CEO Dr. Joanne Pike called out the Centers for Medicare & Medicaid Services (CMS) in a press release for not fully approving the drug.
“Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months — memories, skills and independence. They’re losing time," Pike said in the press release.
In a press release, CMS said it would provide broader coverage of the drug if it received traditional FDA approval.