The U.S. Food and Drug Administration (FDA) has approved Eli Lilly's antibody therapy donanemab (Kisunla®️) for certain adults with Alzheimer's disease.
Early symptomatic Alzheimer's patients consist of those with mild cognitive impairment or mild dementia. In Alzheimer's disease, certain proteins such as amyloid-beta and tau form toxic clusters or plaques in the brain. These are believed to contribute to neurodegeneration and cognitive decline. Kisunla®️ is an antibody designed to recognize a toxic form of amyloid-beta and mark it for clearance by the immune system. It thus works to slow the progression of Alzheimer's disease.
At an FDA advisory committee meeting held last month, members unanimously agreed that the current clinical trial data demonstrated the treatment's effectiveness for early-stage Alzheimer's disease. The committee also expressed the view that the treatment has a favorable risk-benefit profile. Donanemab (Kisunla®️) was thus approved.
In a press release announcing the approval, Lilly stated that “in a pivotal Phase 3 study, Kisunla®️ slowed cognitive and functional decline by up to 35% over 18 months compared to placebo and reduced participants' risk of progressing to the next clinical stage of the disease by up to 39%.”
According to Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer's Drug Discovery Foundation, “This approval marks another step forward in evolving care standards for people living with Alzheimer's disease and will ultimately provide much-needed hope and new treatment options for the affected community.”
Reference: alzheimersnewstoday.com (https://alzheimersnewstoday.com/news/donanemab-approved-early-symptomatic-alzheimers-now-kisunla/)