Green light for new Alzheimer’s therapy in the United StatesThe U.S. Food and Drug Administration (FDA) has approved donanemab (350 mg/20 mL once-monthly injection by intravenous infusion), Eli Lilly and Company’s treatment for adults with early, symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment and people with mild-stage dementia due to AD with confirmed amyloid disease.
Donanemab monthly – the American company underlines in a note – is the first and only therapy targeted to amyloid plaques with evidence to support the interruption of therapy when the amyloid plaques are removed.
“Donanemab has demonstrated very meaningful results in people with early, symptomatic Alzheimer’s disease, for whom there is an urgent need for effective treatment options,” said Elias Khalil, president and CEO of Lilly Italy hub. “We know these medicines have the greatest potential benefit when people are treated early, and we are working closely with many stakeholders to improve the detection and diagnosis of this disease. We are deeply grateful to the patients and their loved ones who have participated in our clinical trials, and to the scientists and collaborators at Lilly who have persevered in research for decades. Every year, more people are at risk of developing this disease, and we are determined to improve their lives.”
How the drug works
Amyloid is a protein naturally produced by the body that can clump together to create amyloid plaques. Excessive accumulation of amyloid plaques in the brain can lead to memory and thinking problems associated with Alzheimer’s disease. Donanemab – the note reports – can help the body remove excessive accumulation of amyloid plaques and slow the decline which can impair people’s ability to remember new information, important dates and appointments, plan and organize, prepare meals, use appliances, manage finances, and maintain independence.
The new drug slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in the pivotal phase 3 study Trailblazer-Alz 2 and reduced the risk of progressing to the next clinical stage of the disease by up to 39%. Donanemab is the first and only therapy targeting amyloid plaque that used a time-limited treatment regimen focused on clearing amyloid plaque. Nearly half of the study participants completed the course of donanemab treatment within 12 months. Infusions once a month, lasting 30 minutesreduced amyloid plaques by an average of 84% compared to the start of the study.
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