FDA approves donanemab, now Kisunla, to treat early Alzheimer’s

Therapy specifically indicated for patients with early symptomatic disease

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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The U.S. Food and Drug Administration (FDA) has approved Eli Lilly‘s antibody therapy donanemab, now Kisunla, for certain adults with Alzheimer’s disease.

Specifically, Kisunla is indicated for patients with early symptomatic Alzheimer’s — to include individuals with mild cognitive impairment or mild dementia, and confirmed evidence of amyloid plaques, the toxic protein aggregates, or clumps, that accumulate in the brain of those with the neurodegenerative disease.

The decision closely follows an FDA advisory committee meeting, held last month, at which members unanimously voted that available clinical trial data demonstrated the treatment’s efficacy for early Alzheimer’s. The committee also found that the therapy had a favorable risk-benefit profile.

Indeed, Lilly noted in a company press release announcing the approval that “Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%.”

According to Howard Fillit, MD, co-founder and chief scientific officer at the Alzheimer’s Drug Discovery Foundation, “this approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer’s community.”

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Patients given Kisulna in trials were able to stop treatment

Kisunla will be administered via into-the-vein (intravenous) infusions once per month, with each infusion lasting about 30 minutes. The dose for the first three infusions is 700 mg, increased to 1,400 mg thereafter.

In clinical trials, patients were able to stop treatment with Kisunla once their amyloid plaques dropped below visually detectable levels on imaging scans. Per the prescribing label, a person’s doctor may also consider stopping Kisunla should this occur with real-world use.

Lilly, which indicated that Kisunla is the first anti-amyloid therapy where this has been shown possible in clinical studies, believes its use could enable lower treatment costs and fewer infusions for patients.

Overall, a six-month course of treatment would be expected to cost about $12,522 in total, according to the company.

The list price of each vial of Kisunla is about $696, but the total out-of-pocket cost for the medication will vary based on a person’s insurance coverage and how long they need to be on treatment.

Coverage and reimbursement for Kisunla is available for eligible patients on Medicare. Lilly Support Services is offering a free patient support program to help eligible individuals navigate treatment with Kisunla, including financial assistance and resources.

The company also plans to donate Kisunla to the Lilly Cares Foundation, a nonprofit that makes medications available at no cost to eligible people who meet certain financial criteria.

In Alzheimer’s, certain proteins, namely amyloid-beta and tau, form toxic clumps, or plaques, in the brain, which are believed to contribute to neurodegeneration and cognitive decline.

Kisunla is an antibody designed to recognize a toxic form of amyloid-beta and mark it for clearance by the immune system, thereby working to slow Alzheimer’s progression. Leqembi (lecanemab), which last year earned full approval from the FDA for treating Alzheimer’s, works in a similar manner.

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Approval welcomed by Alzheimer’s advocates as ‘real progress’

The regulatory approval for Kisulna is backed in part by findings from the Phase 3 TRAILBLAZER-ALZ 2 trial (NCT04437511), in which treatment significantly slowed cognitive declines among people with early Alzheimer’s disease. The therapy was particularly effective among patients who had low to medium tau levels in the brain and who were younger and less cognitively impaired.

About half of patients (47%) achieved sufficient amyloid-beta clearance to be able to stop treatment after a year, and 69% met that mark by 1.5 years.

“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options,” said Anne White, executive vice president of Lilly Neuroscience. “We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis.”

Having a second treatment for early-stage Alzheimer’s gives doctors another reason to detect cognitive decline and accurately diagnose and treat Alzheimer’s at its earliest stages, offering patients the invaluable gift of time.

The most common side effects of Kisunla include headache and brain swelling or brain bleeding, which are collectively known as amyloid-related imaging abnormalities, or ARIAs; such side effects are common with therapies targeting amyloid-beta.

Kisunla comes with a black box warning for ARIAs, which may in rare cases be serious or life-threatening. Patients carrying APOE4, the strongest genetic risk factor for Alzheimer’s, may be at a higher risk of ARIAs.

Allergic reactions, which may also be serious or life-threatening, are also possible, and usually occur during the infusion or in the 30 minutes afterward. The medication should not be used in people with a history of such reactions to Kisunla or any of its ingredients, its label notes.

Members of the Alzheimer’s community welcomed the FDA decision with enthusiasm.

“By slowing the progression of Alzheimer’s with a drug whose treatment can be stopped, early-stage patients and their doctors have a second choice for slowing their progression of the disease,” George Vradenburg, UsAgainstAzheimer’s chair and cofounder, said in a statement.

“Having a second treatment for early-stage Alzheimer’s gives doctors another reason to detect cognitive decline and accurately diagnose and treat Alzheimer’s at its earliest stages, offering patients the invaluable gift of time. It is time to adopt a program for annual cognitive screening to assure that Alzheimer’s is caught early and diagnosed accurately,” he added.

Joanne Pike, president and CEO of the Alzheimer’s Association, called the approval “real progress” in a statement from the nonprofit.

“Today’s approval allows people more options and greater opportunity to have more time,” Pike said, adding that “having multiple treatment options is the kind of advancement we’ve all been waiting for.”

The association also noted that it is working with health systems and providers to aid in ensuring patients have access to the treatment and to promote early detection and diagnosis efforts that will enable patients sooner access to therapies like Kisunla.