Saudi Gazette report
RIYADH — The Saudi Meals and Drug Authority (SFDA) has formally accredited the registration of lecanemab (Leqembi) for the therapy of sufferers with early-stage Alzheimer’s illness, particularly these with delicate cognitive impairment or delicate dementia, who carry no copies or only one copy of the ApoE4 gene variant.
This marks the primary accredited Alzheimer’s therapy within the Kingdom.
In a press release, the SFDA famous that lecanemab is a biologic drug based mostly on monoclonal antibody know-how, and is the primary biologic remedy licensed for Alzheimer’s in Saudi Arabia.
The therapy works by focusing on amyloid beta protein plaques within the mind, an indicator of Alzheimer’s pathology, thereby serving to sluggish cognitive decline.
The drug is run by way of intravenous infusion each two weeks.
The authority mentioned the approval adopted a complete analysis of the drug’s efficacy, security, and high quality, with scientific trials exhibiting that lecanemab slows the development of signs in comparison with placebo, based mostly on established Alzheimer’s illness evaluation scales.
Probably the most generally reported unwanted effects included complications, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA) — mind adjustments detectable by way of MRI which will contain mind swelling or microbleeds.
The SFDA emphasised the significance of ongoing affected person monitoring throughout therapy, significantly for any rising unwanted effects. Genetic testing is required earlier than initiating remedy to evaluate affected person eligibility and scale back danger of antagonistic reactions.
The authority additionally required the producer to submit common post-marketing reviews on the drug’s effectiveness and security, and to implement a danger administration plan to make sure the therapy’s optimum and protected use.