2023-07-29 19:13:37
Pharmaceutical companies submit application for lecanemab in the EU; New biomarker could aid in early detection of Alzheimer’s.
Frankfurt – Howard Fillit, co-founder and scientific director of the US Alzheimer’s Drug Discovery Foundation, expresses his optimism about the potential to revolutionize the treatment and diagnosis of Alzheimer’s disease. Fillit’s positive outlook stems from the recent approval of the Alzheimer’s drug “Leqembi” by the US Food and Drug Administration (FDA) in July, following its provisional approval in January.
“Leqembi,” which contains the active substance lecanemab, targets the protein amyloid-beta, which is known to form clumps in the brain of Alzheimer’s patients. This process can begin up to 20 years before the onset of cognitive impairments. The drug’s approval in the US allows for its use in patients with early-stage Alzheimer’s, with treatment costs amounting to nearly $26,000 per year. In the EU, Biogen and Eisai, the manufacturers of “Leqembi,” have also submitted an application for approval.
Notably, lecanemab must be administered at an early stage of the disease to slow down its progression. Another amyloid antibody on the market, aducanumab, has sparked controversy among experts. However, the next drug from this class of drugs, Donanemab, developed by Eli Lilly, is currently undergoing clinical trials and has shown promise in slowing cognitive decline by 35 percent. Donanemab requires infusions every four weeks, unlike lecanemab, which requires biweekly administration. Both drugs carry the risk of serious side effects, including brain edema and bleeding.
Early and accurate diagnosis of Alzheimer’s is crucial, as treatment with these antibodies is only effective before the notable symptoms are fully manifested. The current gold standard for diagnosis is positron emission tomography (PET), which can detect amyloid and tau in the brain. However, PET scans are complex, expensive, and not readily available for routine diagnostic purposes. A blood test developed by C2N Diagnostics, which detects amyloid beta in the blood, has gained approval in the US and EU.
Researchers are also exploring other biomarkers for early detection and monitoring of Alzheimer’s, such as the tau protein found in the cerebrospinal fluid. A recent study led by neurologist Randall Bateman proposes using a marker called MTBR-tau243 to diagnose Alzheimer’s and monitor the effects of drug therapy on tau proteins during treatment.
The advancements in Alzheimer’s treatment and diagnosis provide hope for patients and their families. However, further research and development are needed to improve accessibility and efficacy of these methods.]
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