US officials have given the green light to a new Alzheimer’s drug that expands available treatment options for people in the early stages of brain decline.
The US Food and Drug Administration (FDA) has approved Eli Lilly’s donanemab, which is sold under the brand name Kisunla.
It comes weeks after an FDA panel of independent advisers voted June 10 to support Eli Lilly’s experimental Alzheimer’s treatment, finding that the drug is effective and that the benefits outweigh the risks.
“Alzheimer’s disease is a devastating disease for the person diagnosed and their loved ones,” Teresa Buracchio, director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said Monday.
“Data from the study conclusively demonstrated that Kisunla reduces the rate of cognitive and functional decline in patients with mild cognitive impairment and mild Alzheimer’s disease dementia.”
Eli Lilly’s donanemab is sold under the brand name Kisunla
Cristina Arias/Cover/Getty Images
It is only the second time the drug has met the high standard set by regulators after a similar drug from Japanese drugmaker Eisai was approved last year to slow cognitive decline in patients.
Both drugs are monoclonal antibodies given as IV infusions that target plaque buildup in the brain caused by the clumping of beta-amyloid protein.
“This is real progress. Today’s approval gives people more options and a greater opportunity to have more time,” Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, said in a statement.
“Having more treatment options is the kind of progress we’ve all been waiting for — all of us touched, even blinded, by this difficult and devastating disease.”
According to the NHS, it also raises hopes that a cure will one day be found for Alzheimer’s disease, which afflicts 940,000 Britons.
How effective is the newest drug?
A clinical trial of donanemab, which included more than 1,300 participants with early symptomatic Alzheimer’s disease, separated participants based on tau levels.
Among participants with “low or moderate” levels of tau, those receiving donanemab had a 35% slower decline in their ability to think clearly and carry out daily activities compared to those receiving an inactive placebo.
When the researchers also included people with high levels of tau — indicating they are further along in the disease — the benefit of donanemab compared with placebo was 22 percent.
In addition, 47 percent of people who took the drug showed no decline in the disease severity test after one year, compared with 29 percent among people in the placebo group.
In addition, 47 percent of people in the “low or moderate” tau group who received the drug showed no decline in the disease severity test after one year, compared with 29 percent among 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 not clear at this stage how it will be decided who should receive the drugs and how long they might benefit.
Some FDA advisers said during a June meeting that more data is needed on the drug’s benefits for black and Hispanic patients, as well as 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 competitor Leqembi.
However, the two drugs were tested on slightly different types of patients, which experts say makes it difficult to compare the drugs’ safety.