The Medicines and Healthcare products Regulatory Agency (MHRA) is expected to make a decision on approval as early as next week. Approval and NHS distribution are still uncertain due to concerns regarding severe side effects, according to experts.
The drugs lecanemab and donanemab are said to potentially slow the progression of Alzheimer’s disease by about a third through the removal of toxic proteins from the brain.
Recent developments in Alzheimer’s treatment have stirred a heated debate among experts, as drugs like lecanemab and donanemab face scrutiny due to their alleged serious risks and modest effects.
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While the Food and Drug Administration (FDA) in America granted approval for lecanemab last year, it came with a stern “black box warning” to caution doctors about potential dangers. Figures from clinical trials indicate alarming statistics, with a reported half a dozen patient deaths, one in 100 experiencing serious side effects, and a third suffering from brain bleeding.
Dr. Madhav Thambisetty, associated with the US National Institutes of Health, raised concerns over these drugs, emphasizing the serious risks of harm or even death. Common side effects include brain swelling and bleeding, with consistent observations of brain tissue loss in trials.
Alzheimer’s, affecting over 600,000 people in the UK, remains the leading cause of dementia without a cure. The urgency to administer these new drugs early to prevent brain cell damage adds complexity, as not all individuals showing early signs of Alzheimer’s will progress to the disease.
Debate Over Alzheimer’s Drugs
Dr. Rob Howard, a dementia expert at University College London, expressed reservations about the drugs’ limited benefits, emphasizing that their impact might not be noticeable to patients or doctors. He voiced concerns about the potential misdiagnosis and the risks associated with administering a treatment that may offer little help and potentially harm.
The Medicines and Healthcare products Regulatory Agency (MHRA) faces a critical decision on the approval of these drugs, with fears stemming from their limited benefits and deadly side effects. David Thomas, head of policy at Alzheimer’s Research UK, emphasized the need for thorough scrutiny given the risks associated with lecanemab and donanemab.
Manufacturers, Eisai and Eli Lilly, defended their products, with Eisai stating that brain volume loss does not correlate with worsening neurodegenerative outcomes. Eli Lilly underscored the importance of discussing the benefits and risks with doctors before treatment authorization.
The decision by the MHRA remains uncertain, and concerns persist over the potential approval of these drugs in the UK, despite their clearance in the US and parts of Asia. The Alzheimer’s community awaits a resolution that balances the need for new treatments with the imperative of ensuring patient safety.
