A second drug for the treatment of Alzheimer’s disease was approved Tuesday by the Food and Drug Administration.
The drug donanemab, marketed by drugmaker Eli Lilly as Kisunla, was tested in a 1,700-person clinical trial over 18 months. Patients who took Kisunla had their cognitive decline slowed by about 22% compared to those who received a placebo.
However, the drug also had potentially deadly side effects. The most common side effect was brain swelling and bleeding. Three deaths were linked to Kisunla, according to the FDA.
“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options,” Eli Lilly Executive Vice President Anne White said in a press release. “We know these medicines have the greatest potential benefit when people are treated earlier in their disease.”
The 1,700 patients in the study all had early or mild Alzheimer’s and were treated with monoclonal antibody infusions every four weeks. Kisunla works by targeting amyloid beta plaques in the brain, a telltale characteristic of Alzheimer’s.
Last year, the FDA approved the drug lecanemab, marketed as Leqembi, from Japanese drug company Eisai. Leqembi works in similar ways and has similar side effects.
A 12-month course of Kisunla will cost patients around $32,000, though Medicare is expected to cover some of the costs. When Leqembi hit the market last year, it cost $26,500 for a 12-month course.
If patients reach a point where amyloid plaque levels in the brain are nearly undetectable, the FDA said doctors can stop prescribing Kisunla, possibly reducing costs.
“As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients,” said Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation.
Medical professionals have been working for years to discover a cure for Alzheimer’s which affects an estimated 6.7 million Americans. That number could increase to 13.8 million by 2060, according to the Alzheimer’s Association.
Earlier this year, a previously approved treatment, Aduhelm, was taken off the market by drugmaker Biogen. The company said it was choosing to focus on its partnership with Eisai on Leqembi.
With News Wire Services
