(TND) — Another treatment for Alzheimer's got federal approval this week, which the Alzheimer’s Association applauded as "real progress" for the nearly 7 million Americans who are living with the degenerative brain disease.
The U.S. Food and Drug Administration on Tuesday announced approval for Eli Lilly’s Kisunla, or donanemab, which can be taken with monthly infusions.
Eli Lilly reported that Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its study.
Japanese drugmaker Eisai got FDA approval last year for a similar Alzheimer's drug – lecanemab, also known by its brand name of Leqembi.
Both drugs try to reduce amyloid plaques in the brains of early-stage Alzheimer’s patients.
Maria C. Carrillo, the chief science officer and medical affairs lead for the Alzheimer’s Association, said Wednesday that amyloid plaques are one of the hallmarks of Alzheimer's.
The other is a buildup of a protein called tau.
“So, amyloid plaques do build up outside of the brain cells, and potentially even maybe a decade or two, two decades prior to symptoms really manifesting,” Carrillo said. “And they block cell-to-cell communication.”
They also cause inflammation, and the prevailing thought is that it triggers an accumulation of tauproteins into tau tangles, which happens inside a neuron. Alzheimer’s patients have an accumulation of amyloid plaques outside neurons and an accumulation of tau tangles inside neurons.
“Decades of this buildup does indeed progressively rob individuals of their ability to think and remember,” she said. “First, it'll block remembering of short-term information and activities that are being conducted. And over time, even automatic functions are impacted, and long-term memory is impacted, unfortunately, ultimately leading to death from Alzheimer's or with Alzheimer's disease.”
Carrillo said both Leqembi and the newly approved Kisunla work best when the disease is detected and treated early.
“Having multiple treatment options like Kisunla, like Leqembi, allow people to have options for treatment that we've been waiting for quite a few decades, so we are very excited,” she said. “But know that this is only our beginning. We need more effective drugs, and we will have not only more effective drugs, but a combination of drugs very soon. So, this is our beginning, and we're very excited about it.”
Carrillo cautioned that results would vary for folks, but the results of Eli Lilly’s clinical trial show promise that early Alzheimer’s patients could gain months of additional time living independently or fully participating in daily life.
“More time to attend a graduation or a birth of a grandchild, so that is a very impactful, I think, benefit from these drugs in particular,” she said.
Carrillo said Centers for Medicare & Medicaid Services should cover the treatments if prescribing physicians participate in a registry. And she said it’s important for clinicians to register their patients who are taking these drugs so medical researchers can follow them over time and learn more about the impact and risks of the drugs. That could be her group’s registry, the Alzheimer’s Network for Treatment and Diagnostics.
These treatments can certainly change the course of Alzheimer's in a very meaningful way, Carrillo said.
“But, as with all therapies for serious diseases, including Alzheimer's, in addition to benefits, there are side effects,” she said.
Those could include slight brain swelling and microbleeds in the brain, which were noted by the FDA.
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