New Alzheimer’s drug wins approval after FDA delay

The U.S. Food and Drug Administration on Tuesday approved another drug that slows cognitive and functional decline in people with early symptomatic Alzheimer’s disease, including mild cognitive impairment or mild dementia.

The drug, donanemab-azbt, produced by Eli Lilly, doesn’t cure the neurodegenerative disease. But in clinical trials it slowed progression, according to the Alzheimer’s Association , which had urged swift approval.

The drug will be marketed as Kisunla. In the phase 3 clinical trial, those receiving the drug declined cognitively about 35% more slowly than those receiving a placebo infusion, Eli Lilly reported in a news release about the approval. The notice said the drug “reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%.”

Approval had been expected earlier, but in March, the FDA stunned those awaiting access to the drug by delaying action, as Deseret News reported . The agency said it wanted to have an advisory committee look at the safety and efficacy more closely, reportedly worried about the potential for brain bleeds.

Donanemab is a lab-created monoclonal antibody that works by clearing amyloid beta plaques in the brain. Those plaques are believed to be a key factor in development of Alzheimer’s, a neurodegenerative disease that affects at least 6 million older adults in the U.S.

Deseret News reported that “compared to other trials using therapy targeting amyloid beta, the trial participants had more advanced disease and all of them benefited from donanemab,” citing the company.

Early clinical results showed that about half the 1,736 trial participants, who were from eight countries, completed their participation by reaching the end point of clearing the plaque in as little as six to 12 months. The drawback, however, was potential for brain swelling and tiny hemorrhages, seen among some of the study participants. That led to the FDA decision to delay approval and have more study done.

Leqembi and Aduhelm

Two other drugs have previously been approved that also targeted the plaques: Aduhelm and Leqembi. Aduhelm sparked controversy and failed commercially after it was approved against the advice of an advisory panel; Biogen has since stopped producing it. Leqembi, developed by Biogen and Eisai, also won approval, but the Aduhelm controversy slowed its uptake for a while as Medicare waffled on whether it would cover the drug. Medicare officials decided to cover the drug if it won full FDA approval, which it did.

A delay, not a cure

In the case of both drugs, the prognosis is slower degeneration, not an end to it.

“The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Eli Lilly’s drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling,” The Associated Press reported Tuesday after the approval was announced.

But health care providers and patient advocates have all along told Deseret News that time matters when it comes to building memories with those who have memory loss. A few months can be long enough to attend a child’s wedding or see a loved one graduate from high school or college.

In June, a panel of FDA advisors voted unanimously to recommend approval, noting benefits outweighed the risk of side effects. At the time, groups advocating for those who have Alzheimer’s and their families expressed satisfaction with the support. This week, they hailed the approval.

“We are encouraged by the FDA’s approval of donanemab and are optimistic that it will make a positive difference in the lives of individuals living with Alzheimer’s disease and their family caregivers. As with any medication, patient access and affordability to those in need is vitally important and we hope the FDA’s actions will facilitate both,” the Alzheimer’s Foundation of America said in a written statement.

“This is another positive sign of further progress, but we must keep moving forward until we reach the finish line — a cure for Alzheimer’s disease. Federal policymakers must continue increasing investments in Alzheimer’s disease research and support services for caregivers to provide help and hope to the millions of Americans living with Alzheimer’s,” the group continued.

Delivering the drug

The drugs are not cheap. AP reported that Kisunla’s cost would “vary by patient, depending on how long they take the drug,” per Eli Lilly.

Kisunla is prescribed in a half-hour monthly infusion, while Leqembi is infused twice a month.

A year’s supply of Kisunla would cost $32,000, which is more than Leqembi’s $26,500 price tag. But with Kisunla, doctors have an option to stop prescribing the drug if they want after scans show patients have “minimal plaque,” according to AP.

The company’s news release noted it’s the “only amyloid-plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.”