Health regulators are being strongly encouraged to swiftly approve two groundbreaking drugs for mild to moderate dementia stage of Alzheimer's disease.
This urgency stems from the need to prevent millions of individuals who could benefit are not left in limbo, The Guardian reported.
(Photo : SEBASTIEN BOZON/AFP via Getty Images) A woman suffering from Alzheimer's disease has the hand of a relative on March 18, 2011 in a retirement home in Angervilliers.
Urging Regulators to Fast Track Approval of Two Alzheimer's Drugs
Experts urge regulators to fasten the approval of two recently launched medications that could potentially be a game-changer in Alzheimer's disease treatment. These drugs may benefit individuals in the disease's initial phases, making it more crucial to fast-track their approval.
Based on the conclusive findings of a recent study, it verified that Donanemab, developed by Eli Lilly, effectively decelerated cognitive decline in individuals with Alzheimer's disease by 35%. In the previous year, Lecanemab, a drug produced by Eisai and Biogen, demonstrated a reduction in the decline rate by 27%.
By slowing down the advancement of the disease, individuals affected by Alzheimer's may be able to maintain their independence for an extended period. This is significant because Alzheimer's is a degenerative condition that impairs cognitive functions and daily living activities.
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Limited Treatment Options
Traditionally, there have been limited treatment options for Alzheimer's, focusing mainly on managing symptoms rather than addressing the underlying disease process.
Given the crucial impact of timely intervention on patient response to treatment, the executive director of research and partnerships at Alzheimer's Research UK, Dr. Susan Kohlhaas, is among the advocates urging regulators to take swift action, with a goal to maximize the broadest range of benefits achievable from the new drugs.
Kohlaas told The Guardian, "We now have two potentially life-changing Alzheimer's treatments on the horizon, and we need to see rapid regulatory decisions so people who could benefit from these treatments aren't left in limbo."
Considering the two-decade-long absence of new Alzheimer's medications, the doctor added that it is essential that individuals impacted by this disease receive timely information and access to new treatment.
While Leqembi, whose generic name is lecanemab, obtained approval from the US Food and Drug Administration (FDA) earlier this month, regulatory authorities in the UK and Australia have yet to authorize either of these medications.
Both drugs function by decreasing the levels of cerebral amyloid, a protein widely recognized as a major target in the treatment of Alzheimer's disease.
After the FDA granted full approval to it, Leqembi became known as the world's first Alzheimer's medication. It focuses on targeting and combating specific proteins in the bodies of individuals with Alzheimer's disease, thereby reducing the progression of the illness.
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