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FDA has given accelerated approval to Lecanemab-irmb for Alzheimer’s disease management.
On 6 January 2023, the United States Food and Drug Administration (US-FDA) approved Lecanemab-irmb via the accelerated approval pathway to treat Alzheimer’s disease, an irreversible, progressive brain disorder. Under this pathway, the US-FDA can sanction agents for severe conditions where there is an unfulfilled medical requirement and a medication is demonstrated to have an impact on a surrogate endpoint that is likely to anticipate favorable benefits to patients.
Lecanemab-irmb is the 2nd drug in a newly authorized class for Alzheimer's disorder that addresses the basic pathogenesis and depicts a significant advancement in the ongoing fight to effectively combat neurodegenerative disorders. It is the most recent therapy for targeting the underlying process of Alzheimer's illness rather than merely mitigating the symptoms. Recently, the findings of a Phase 3 randomized controlled trial to substantiate Lecanemab's clinical benefits have been reported. The agency anticipates to procure the data soon.
In a parallel-group, double-blind, dose-finding, placebo-controlled study that recruited 856 Alzheimer's disease-affected people, investigators explored Lecanemab-irmb's efficacy. When there was confirmation of amyloid beta pathology in people having mild cognitive dysfunction or mild dementia, treatment was commenced. Individuals getting Lecanemab's suggested dose of 10 mg/kg every 2 weeks exhibited a considerable decrease in brain amyloid plaques from baseline to Week 79 in comparison with the placebo arm, in which there was no decrease in amyloid beta plaque. Individuals getting the treatment had a noticeable dose- and time-dependent decrease of amyloid beta plaque.
The expedited approval of Lecanemab-irmb is supported by these findings, which are based on the apparent decline in the levels of amyloid beta plaque, a sign of Alzheimer's illness. The amyloid beta plaque amount in the brain was estimated with the aid of positron emission tomography imaging. This was done to compare amyloid beta plaque levels in a composite of brain regions that were anticipated to be profoundly impacted by Alzheimer's illness pathology to a brain region that was predicted to be spared from such a pathology. Lecanemab-irmb's prescribing information encompasses a warning for amyloid-related imaging abnormalities (ARIA), that are renowned to happen with the antibodies of this class.
ARIA generally does not show symptoms, although severe and life-threatening incidents rarely may occur. Despite the fact that few people might experience symptoms like nausea, disorientation, headache, dizziness, seizures, and altered vision, ARIA's most common sign is transient swelling in certain brain regions that usually goes away with time. Lecanemab-irmb also comes with a warning about the possibility of infusion-associated responses, which can cause flu-like symptoms, alteration in blood pressure, vomiting, and nausea.
The most frequent adverse effects included headache, ARIA, and infusion-associated problems. Lecanemab-irmb is prescribed to combat Alzheimer's disorder, as stated in the prescribing information. As per the labelling, individuals suffering from mild dementia or mild cognitive impairment stage of the illness—the population in which treatment was assessed in clinical trials—should be given Lecanemab-irmb. No safety or effectiveness data exists on commencing therapy at earlier or later stages of the illness than were investigated, according to the labelling.
US-FDA
FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment
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