US authorities have given the green light to a new drug against Alzheimer’s disease, expanding the treatment options available to people in the early stages of brain decline.
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s donanemab. The drug is sold under the brand name Kisunla.
This comes just weeks after a panel of independent advisers to the FDA voted June 10 to endorse Eli Lilly’s experimental Alzheimer’s drug, concluding that the drug is effective and its benefits outweigh its risks.
“Alzheimer’s disease is a devastating disease for the person diagnosed with it and their loved ones,” Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement Monday.
“The study data have convincingly demonstrated 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.”
Eli Lilly’s donanemab is sold under the brand name Kisunla
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It is only the second time that a drug has met the regulators’ high standard. Last year, a similar drug from Japanese pharmaceutical company Eisai was approved for slowing cognitive decline in patients.
Both drugs are monoclonal antibodies given through an IV that target the buildup of plaques in the brain caused by clumping together of the beta-amyloid protein.
“This is real progress. Today’s approval gives people more options and a greater chance to have more time,” Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, said 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, or even surprised, by this difficult and devastating disease.”
It also raises hopes that a cure will one day be found for Alzheimer’s, a disease that affects 940,000 Britons, the NHS says.
How effective is the latest drug?
In the donanemab clinical trial, which included over 1,300 participants with early symptomatic Alzheimer’s disease, participants were classified based on tau levels.
Among participants with “low or average” tau levels, those who received donanemab had a 35% slower decline in the ability to think clearly and perform daily activities, compared with those who received an inactive placebo.
When researchers also included people with high tau levels – suggesting they are at a more advanced stage of the disease – the benefit of donanemab compared with placebo was 22 percent.
In addition, 47 percent of people who received the drug showed no decline in a test to determine disease severity after one year, compared with 29 percent of people in the placebo group.
In addition, 47 percent of people in the “low or average” tau group who received the drug showed no decline in a test of disease severity after one year, compared with 29 percent of people in the placebo group.
It is only the second time the FDA has approved a drug to slow cognitive decline in patients.
PEXELS
Uncharted waters
It is currently unclear how it will be determined who will receive the medication and how long they will benefit from it.
At the June meeting, some FDA advisers said more data is needed on the drug’s benefits for black and Hispanic patients, and for other groups.
The main safety concern 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 on slightly different types of patients, making it difficult to compare the safety of the drugs, experts say.