From UPSC perspective, the following things are important :
Mains level: How Does Donanemab Work?
Why in the News?
Donanemab, a new Alzheimer’s disease therapy developed by Eli Lilly, has gained unanimous support from independent scientists advising the US Food and Drug Administration (FDA), moving it closer to clinical use.
What is Donanemab?
How Does Donanemab Work?
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How do the benefits of the drug stack up against its risks?
- Target Population: The drug is intended for those in the early stages of Alzheimer’s disease (mild cognitive impairment or mild dementia).
- Benefits: Significant clinically meaningful slowing of the disease, allowing patients to retain their functions for a longer time. Phase 3 study shows a 35.1% slowdown in cognitive decline in early Alzheimer’s patients over 76 weeks.
- Risks: Main adverse effects include brain swelling (24%) and brain bleeds (19.7%), with most cases being asymptomatic.Three treatment-related deaths reported.Amyloid-related imaging abnormalities (ARIA) like brain bleeds and seizures were mostly non-serious and resolved after discontinuation of therapy.
- Risk Management: The key risks can be mitigated through appropriate labeling and clinical monitoring. Further risks will be characterized through post-authorization studies.
Why is a breakthrough of this kind important?
- Rising Burden of Alzheimer’s: The global population is ageing, leading to an increased burden of diseases like Alzheimer’s. In India, 5.3 million people are currently living with dementia, expected to rise to 14 million by 2050.
- Lack of Effective Treatments: There are limited options for disease-modifying treatments for Alzheimer’s. Innovations like donanemab are crucial for providing new hope and potential therapies.
- Economic Considerations: While the drug is expensive, it offers the potential for several more years of quality life for patients.
Why was the approval for the drug delayed?
- Additional Data Requirements: The USFDA wanted to understand further the data relating to the therapy, especially regarding the limited dosing protocol used during trials.
- Limited Dosing Protocol: During the trial, therapy was stopped in patients who achieved a certain level of amyloid beta plaque clearance, which is a distinguishing feature of donanemab compared to other therapies.
- Previous Drug Approval Irregularities: Scrutiny increased after irregularities were found in the approval process of the first drug, aducanumab, which involved close collaboration between the regulator and the drugmaker and approval despite negative trial outcomes. The second drug, lecanemab, also had cautious optimism from doctors due to its demonstrated efficacy with fewer side effects.
Conclusion: Ensure rigorous and transparent review processes for new Alzheimer’s treatments, incorporating comprehensive data analysis and post-authorization studies to monitor long-term safety and efficacy.
Mains PYQ:
Q Stem cell therapy is gaining popularity in India to treat a wide variety of medical conditions including leukaemia, Thalassemia, damaged cornea and several burns. Describe briefly what stem cell therapy is and what advantages it has over other treatments? (UPSC IAS/2017)
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