In a significant breakthrough, the United States (US) Food and Drug Administration (FDA) has granted full approval for lecanemab (also known as Leqembi), making it the first drug to effectively slow the progression of Alzheimer's disease. This development has been praised as a major advancement in the battle against the debilitating condition.
The decision to approve the drug was based on compelling data obtained from a study involving approximately 1,800 patients, demonstrating a remarkable 27% reduction in cognitive and functional decline over an 18-month period. Experts have equated this improvement to a five-month delay in the disease's progression.
Breakthrough Alzheimer's Disease Drug That Slows Cognitive Decline Receives Full US Approval, UK Decision Looms
Newly Approved Drug Marks a New Era
Lecanemab, developed jointly by Eisai in Tokyo and Biogen in Cambridge, Massachusetts, is administered intravenously every other week. As per CNN's report, it is specifically intended for individuals in the early stages of the disease, such as those with mild cognitive impairment or mild dementia, who have confirmed amyloid plaques in their brains.
Approximately one-sixth of the more than 6 million Americans diagnosed with Alzheimer's fall into this category. However, people with advanced forms of the disease may not experience the same benefits from the drug and could face increased safety risks. Further research is needed to determine the drug's effectiveness for individuals with moderate or severe Alzheimer's.
While the drug is not a cure, it has been hailed by the Alzheimer's Association as a significant development. It provides individuals in the early stages of Alzheimer's with more time to maintain their independence and engage in activities they love. The treatment offers the potential for additional months of recognizing loved ones, driving safely, managing finances, and participating fully in hobbies and interests.
However, it's important to note that lecanemab has side effects, including brain swelling or bleeding, and requires regular brain imaging for monitoring. The FDA has included a boxed warning to inform patients and caregivers about these potential risks.
Healthcare systems have been preparing for the broader use of the drug, with infusion centers anticipating an increase in patient referrals. However, not everyone with early Alzheimer's is expected to seek immediate treatment. It is estimated that the number of individuals opting for the drug will gradually rise over time as therapeutic options become more available and testing is reimbursed.
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United Kingdom Still Awaiting the Drug's Approval
The drug's approval in the UK is on the horizon, with regulators led by the Medicines and Healthcare Products Regulatory Agency (MHRA) eagerly considering its potential, MailOnline reported.
This promising step forward provides hope for individuals suffering from Alzheimer's, as well as their families and caregivers, who may soon have access to a treatment capable of slowing the advancement of the disease.
Alzheimer's Research UK has urged the MHRA to expedite the review process without compromising quality, emphasizing the importance of providing clarity to individuals with Alzheimer's in the UK.
They believe that a swift regulatory decision on lecanemab will enhance the UK's reputation as a leader in dementia research, attract more investment in clinical trials, and ultimately benefit those affected by the disease.
Professor David Curtis from the University College London Genetics Institute expressed that the news is remarkable, highlighting the potential for treating or preventing Alzheimer's rather than just enduring it. While concerns about side effects and treatment costs remain, the approval of lecanemab signifies the possibility of addressing Alzheimer's as a manageable condition.
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