Can the new Alzheimer’s drug, Lecanemab, be effective enough?
- January 10, 2023
- Posted by: OptimizeIAS Team
- Category: DPN Topics
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Can the new Alzheimer’s drug, Lecanemab, be effective enough?
Subject: International relations
Context:
- The United States Food and Drug Administration (USFDA) has granted fast-track approval to an Alzheimer’s medicine which, initial results show, reduces the amyloid beta protein deposition in the brain – a classic symptom of the neurodegenerative disease.
Two new drugs that got approval fro US FDA:
- Two drugs that have received a lot of attention in recent weeks are aducanumab (marketed as Aduhelm) and lecanemab.
- The drug Lecanemab, marketed as Leqembi, is the second such monoclonal antibody to receive approval from the regulator. (First one is Aducanemab.)
- Its accelerated approval, a protocol used for serious conditions for which not many treatments exist, was based on a “surrogate endpoint” – there was a statistically significant reduction in amyloid beta plaques at week 79 in 856 Alzheimer’s patients who took the medicine, according to the statement from USFDA.
- Both drugs showed a substantial reduction in amyloid in the brain. But whether this reduction in amyloid resulted in a meaningful benefit in memory and thinking is less clear.
- The Food and Drug Administration in the United States granted accelerated approval for aducanumab and Lecanemab as it thought the drug would improve or slow Alzheimer’s symptoms.
- Lecanemab resulted in a 27 per cent slower decline in memory and thinking ability.
Concerns:
- The results were encouraging only when it was administered to patients with mild cognitive impairment or mild dementia.
- There is no evidence yet of its interventionist potential in advanced cases.
- Another medicine called Aducanemab, got approval in 2021, and developed by Japanese and American companies Eisai and Biogen, also shows less effective than what it claimed.
- Side effects include- Brain swelling and small brain bleed as detected on brain scans.
- High cost of drugs- Aducanumab costs US$28,200 (A$42,000) per patient per year, and the cost of Lecanemab is $26500/ year.
About Alzheimer’s disease:
- In Alzheimer’s disease, Amyloid protein builds up in the brain, which further triggers the development of Tau (a protein) which induces memory loss.
- Beyond amyloid and tau, a range of other biological, genetic, lifestyle, and environmental factors can also contribute to Alzheimer’s disease.