UNITED STATES – Inaprubahan na ng US Food and Drug Administration (FDA) nitong Huwebes, Hulyo 6 ang kauna-unahang gamot na napatunayang nagpapabagal sa paglala ng Alzheimer’s disease.
Ayon sa FDA, ang pag-apruba ay nakabatay sa clinical data na nagpapakita ng epekto sa “surrogate endpoint” na “reasonably likely to predict a clinical benefit to patients.”
Ang gamot na Leqembi, na nagpapabagal sa cognitive decline ng 27% sa loob ng 18 buwan, ayon sa clinical trial.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” sinabi ni Teresa Buracchio, acting director ng Office of Neuroscience sa Center for Drug Evaluation and Research ng FDA.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” dagdag ni Buracchio. RNT/JGC
