USC, UCLA doctors among clinical trial team behind breakthrough Alzheimer's drug, Leqembi
Richard and Maureen Wade have been together for more than 50 years, but the last five have been a challenge.
"Every morning it's a brand new fresh heartbreak when I see a tiny bit more of her that's impaired and there's nothing I an do," said Richard. "An hour from now she won't remember much of the details of this interview."
Half a decade ago, doctors diagnosed Maureen with Alzheimer's, the most common type of dementia which slowly destroys the patient's cognitive skills.
For more than a century there was no treatment for the debilitating disease, leaving people like Maureen to slowly lose precious memories and the ability to think. But on Thursday researchers finally received FDA approval for a breakthrough drug, Leqembi (pronounced "leh-KEM-bee").
"That would be great! Give her more time to be herself," said Richard after hearing the news. "That would be wonderful."
The FDA's initial approval in January was based on one mid-stage study of 800 people with early signs of Alzheimer's who were still able to live independently or with minimal assistance. Eisai, one of the drugmakers that created Leqembi, later published the results of a larger 1,800-patient study that the FDA assessed as part of the full approval process.
According to the latest news release, the FDA's decision was unanimous, with all committee members voting that the study results verified the drug's benefit.
"It's clear this drug slows disease progression and this is the first time we've accomplished that and that's I think a huge step," said Dr. Paul Aisen, a USC neurologist.
Aisen is also the director of the Alzheimer's therapeutic research team that was part of the clinical trials.
"Everybody's different but by and large, people who were treated for the drug as opposed to the placebo slowed progression," he said.
The study showed that the drug slowed down the progression of Alzheimer's by almost 30%.
"We were very pleased by the results. It offers a modest benefit when given over a year and a half," said Dr. Keith Vassel, who had several patients in the trial at UCLA. "It can slow the disease course, in real-world terms, by about five or six months."
Five or six months of no decline would mean the world to families like the Wades.
"It's the being passive and helpless that's the most frustrating," said Richard. "We want to do something where we are fighting back."
Leqembi treatments would cost about $26,000 a year, or about $1000 a session. Medicare said it will pay 80% but not everyone will qualify. Treatments also have to be closely monitored by a doctor as there can be serious side effects.
