Alzheimer's breakthrough as FDA approves new treatment: Scientists hail 'moment we've all been waiting for'

It comes weeks after a panel of independent advisors to the FDA voted June 10 to endorse Eli Lilly’s experimental Alzheimer’s medication, finding that the drug is effective, and the benefits outweigh the risks.

“Alzheimer’s disease is a devastating disease for the person diagnosed and their loved ones,” said Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research in a statement on Monday.

“The trial data demonstrated, convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease.”

It is only the second time a drug has reached the high benchmark set by regulators, after a similar drug last year from Japanese drugmaker Eisai was approved for slowing cognitive decline in patients.

Both drugs are monoclonal antibodies, given as IV infusions, that target the buildup in the brain of plaques caused by the clumping together of the beta-amyloid protein.

“This is real progress. Today’s approval allows people more options and greater opportunity to have more time,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO in a statement.

“Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.”

It also raises hopes of one day finding a cure for Alzheimer's, which afflicts 940,000 Britons, reckons the NHS.

How effective is the latest drug? 

The clinical trial for donanemab, which included more than 1,300 participants with early symptomatic Alzheimer’s disease, separated participants based on the level of tau.

Among participants with “low or medium” levels of tau, people who received donanemab had a 35% slower decline in the ability to think clearly and perform daily activities, compared to those receiving an inactive placebo.

When researchers also included people with high levels of tau — which suggests they are further along in the course of the disease — the benefit of donanemab compared to placebo was 22 percent.

In addition, 47 percent of people who received the drug showed no decline on a test of disease severity after one year, compared to 29 percent among people in the placebo group.

In addition, 47 percent of people in the “low or medium” tau group who received the drug showed no decline on a test of disease severity after one year, compared to 29 percent among people in the placebo group.

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Uncharted waters 

It's unclear at this stage how it will be decided who should get the drugs and how long they might benefit.

Some FDA advisors said during the June meeting that more data are needed on the benefits of the drug for Black and Hispanic patients, as well as other groups.

The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs. The rates reported in Lilly's study — including 20 percent of patients with microbleeds — were slightly higher than those reported with rival Leqembi.

However, the two drugs were tested in slightly different types of patients, which experts say makes it difficult to compare the drugs' safety.