The US Food and Drug Administration (FDA) approved a new drug from Eli Lilly, Kisunla, designed to treat the early symptoms of Alzheimer’s disease. The FDA announced on Tuesday that Kisunla should be used for “patients with mild cognitive impairment or mild dementia stage of disease.”
In its statement, the FDA noted that “patients treated with Kisunla demonstrated a statistically significant reduction in clinical decline,” along with improvements across a range of other criteria.
Kisunla, the brand name for the drug donanemab-azbt, joins a limited selection of drugs currently approved by the US regulator to treat Alzheimer’s, a condition that affects over 6.5 million Americans.
“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease,” said Anne White, Eli Lilly’s executive vice president. “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.”
The Alzheimer’s Association, a leading non-profit organization dedicated to eradicating the disease, welcomed the FDA’s decision. “This is real progress,” said Joanne Pike, the association’s president. “Today’s approval allows people more options and greater opportunity to have more time.”
“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,” Pike added.
Alzheimer’s disease is characterized by the build-up of two key proteins, tau and amyloid beta, into tangles and plaques, known together as aggregates. These aggregates cause brain cells to die and lead to brain shrinkage.
The approval of Kisunla marks a significant step forward in the treatment of Alzheimer’s, providing new hope for patients and their families.
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