Alzheimer's is a debilitating condition that disrupts normal brain function and leads to cognitive decline. The disease is characterized by the accumulation of toxic proteins called amyloid plaques and tau tangles, which impair neuronal activity and eventually cause cell death. Leqembi, also known as lecanemab, has recently received full approval from the FDA in July 2023, marking a significant milestone in the treatment of Alzheimer's.
Leqembi received a conditional approval for Leqembi in January of 2023, and that decision was based on its potential side effects. These potential side effects were concerns of amyloid-related imaging abnormalities (ARIA), which were observed at a higher rate in patients treated with Leqembi compared to those receiving a placebo. Additionally, there was an increased incidence of brain bleeds in patients taking Leqembi. These safety concerns raised questions about the drug's overall risk-benefit profile. Read more about the conditional approval from January 2023 here.
Despite these safety concerns mentioned by the FDA, the FDA's decision to grant full approval to Leqembi reflects the agency's recognition of the drug's potential clinical benefits. The approval was based on results from a larger and more recent clinical trial published in the New England Journal of medicine that demonstrated a 27% slower decline in cognition and function among participants receiving Leqembi compared to those on a placebo. This study provided evidence that the FDA needed in order to approve Leqembi.
One main challenge is the capacity of Alzheimer's treatment centers to handle the potential influx of patients seeking Leqembi. With an estimated 6 million people in the U.S. living with Alzheimer's, the demand for the drug could place a strain on healthcare facilities. Additionally, the administration of Leqembi requires extensive monitoring through MRIs necessary to detect any ARIA, a known side effect associated with Leqembi.
The launch of Leqembi on the market is highly anticipated by Eisai and Biogen and millions of patients around the world depending on this drug to pause cognitive decline. Analysts at Biopharma Dive predict that Leqembi could generate significant annual sales, with estimates reaching up to $10 billion. However, the success of Leqembi's commercialization depends on addressing various challenges.
Sources: National Institute of Aging, National Institute of Aging, Wiki, Biogen, New England Journal of Medicine, Alzheimer’s Association, Biopharma Dive
