Biotech
Wednesday, July 3rd, 2024 2:30 pm EDT
Key Points
- The FDA has granted approval to Eli Lilly’s Alzheimer’s drug donanemab, branded as Kisunla, marking a significant advancement in treating early symptomatic Alzheimer’s disease in the U.S. This approval is crucial amid rising Alzheimer’s cases, affecting nearly 7 million Americans and projected to grow significantly by 2050.
- Donanemab’s approval follows a challenging path, initially rejected last year due to insufficient data and delayed in March. However, it gained favor after an FDA advisory panel recommended approval, citing favorable risk-benefit profiles. Donanemab, along with Biogen’s Leqembi, targets amyloid plaques to slow Alzheimer’s progression in early-stage patients.
- Clinical trials show Eli Lilly’s drug can slow Alzheimer’s progression by 35% over 18 months compared to a placebo. It involves monthly infusions and costs between $12,522 and $48,696 for courses ranging from six to 18 months, with Medicare coverage available. However, both donanemab and Leqembi carry risks, including severe side effects like amyloid-related imaging abnormalities (ARIA), emphasizing ongoing challenges in Alzheimer’s treatment despite therapeutic advancements.
The Food and Drug Administration (FDA) has granted approval to Eli Lilly’s Alzheimer’s drug donanemab, branded as Kisunla, marking a significant advancement in the treatment landscape for early symptomatic Alzheimer’s disease in the U.S. This approval comes as a boon amidst the increasing prevalence of Alzheimer’s, affecting nearly 7 million Americans and projected to rise sharply by 2050. Joanne Pike, CEO of the Alzheimer’s Association, hailed the approval as a pivotal moment, offering patients and caregivers more treatment options to combat this devastating disease.
For Eli Lilly, this approval follows a challenging path to market acceptance. Initially rejected due to insufficient data last year, and subsequently delayed in March, donanemab finally won favor after an FDA advisory panel recommended its approval last month, citing favorable risk-benefit profiles. Donanemab now enters the market alongside Biogen’s Leqembi, both monoclonal antibodies targeting amyloid plaques in the brain to slow disease progression in early-stage Alzheimer’s patients.
Clinical trials indicated that Eli Lilly’s drug can slow Alzheimer’s progression by 35% over 18 months compared to a placebo, allowing patients to switch to a placebo after achieving amyloid plaque clearance goals within specified timeframes. However, the treatment regimen involves monthly infusions and comes at a substantial cost: estimated at $12,522 for a six-month course, escalating to $48,696 for an 18-month treatment period, with Medicare coverage available for eligible patients.
Despite these advances, neither donanemab nor Leqembi represent a cure for Alzheimer’s. Both drugs carry significant risks, including severe and potentially fatal side effects like amyloid-related imaging abnormalities (ARIA), which led to fatalities in some late-stage trial participants. This underscores the ongoing challenges and complexities in Alzheimer’s treatment, as highlighted by the withdrawal of Biogen and Eisai’s Aduhelm following criticism over its controversial approval process in 2021.
In conclusion, the approval of donanemab marks a critical milestone in Alzheimer’s research and treatment, offering hope to patients and families grappling with this relentless disease while underscoring the need for continued vigilance in managing treatment risks and optimizing patient outcomes.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/07/02/fda-approves-eli-lilly-alzheimers-drug-donanemab.html
