The United Arab Emirates became the second country in the world to approve the use of the first and only drug for the treatment of early stages of Alzheimer’s disease.
On Sunday, the Department of Health and Prevention (MoHAP) announced that it had obtained the green light for the registration and use of the drug Aduhelm (aducanumab) from Biogen after its approval by the Food and Drug Administration ( FDA).
Aduhelm is supplied as injections containing a dose of 100 ml. The drug is prescribed to patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) by reducing beta-amyloid plaques in the brain.
On this occasion, Rachid Azar, Executive Vice-President of the Alzheimer’s and Cognitive Impairments Business Unit, declared: “We believe that this drug will benefit patients with early-stage Alzheimer’s disease, their families and providers. They have been waiting for scientific progress in this regard for decades.
Azar thanked the UAE Ministry of Health for its effective response to the unmet needs of Alzheimer’s patients and its rapid review of the drug Aduhelm.
The efficacy of Aduhelm has been evaluated in two phase 3 clinical trials — EMERGE (study 1) and ENGAGE (study 2) —in patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia). with confirmed presence of amyloid pathology. The effects of the drug were also evaluated in the Phase 1b double-blind, randomized, placebo-controlled, dose-finding study, PRIME (Study 3).
Dr Paul Aisen, Alzheimer’s Therapeutic Research Institute (ATRI), University of Southern California, said: “For the first time in history, we have achieved an unprecedented feat by going beyond the treatment of symptoms of Alzheimer’s disease to target its main causes. detection and diagnosis of MCI will allow us to identify patients likely to benefit from this innovative treatment.