The FDA has approved Donanemab, set to be marketed as Kisunla, for use in adults exhibiting early symptoms of Alzheimer’s.
CNBC reported that there are nearly 7 million Alzheimer’s patients in the U.S. alone.
The Alzheimer’s Association identifies Alzheimer’s disease as the fifth leading cause of death among adults over 65 in the U.S.
According to their projections, the number of individuals with Alzheimer’s disease in the U.S. will nearly double to 13 million.
Donanemab faced a challenging journey to approval.
Last year, the FDA rejected it due to insufficient clinical trial data. Its approval was further delayed unexpectedly in March.
Earlier this month, the FDA’s external advisory committee recommended full approval for Donanemab, foreshadowing FDA approval. The committee concluded that the benefits outweigh the risks.
Donanemab is poised to rival Leqembi, which is produced by Biogen in collaboration with its Japanese partner Eisai.
Leqembi has already begun distribution following FDA approval last summer.
Biogen and Eisai previously marketed a dementia drug called Aduhelm but halted sales recently.
Aduhelm was the first drug aimed to reduce amyloid plaques in the brains of Alzheimer’s patients.
Despite facing backlash after the advisory committee recommended against approval in 2021, the FDA ultimately approved it.
Donanemab and Leqembi represent the culmination of 30 years of development in Alzheimer’s treatment.
Both drugs are monoclonal antibodies designed to remove toxic amyloid plaques found in the patient’s brain. While they do not cure Alzheimer’s, they play a role in slowing its progression at an early stage.
However, both Donanemab and Leqembi also pose risks of severe side effects. These include brain swelling, known as brain edema, and bleeding in the brain, known as cerebral hemorrhage.
Side effects can be severe, potentially resulting in death.
During phase 3 clinical trials of Eli Lilly’s Donanemab, three patients died from these serious side effects.
Eli Lilly has added an Alzheimer’s drug to its arsenal. The company has produced GLP-1 diabetes treatment, Mounjaro, and obesity treatment, Zepbound, both based on the same active ingredient.
Eli Lilly ranks tenth globally with a market capitalization of $815.7 billion, making it the largest pharmaceutical company in the world by market cap.
