Biogen’s Aduhelm (aducanumab) injections get governemnt go-ahead
The UAE has become the world’s second country to approve the use of the the first and only drug for the treatment of early stages of Alzheimer’s disease.
On Sunday the Ministry of Health and Prevention (MoHAP) announced that it had got the go ahead for the registration and use of the drug Biogen’s Aduhelm (aducanumab) after it was approved by the Food and Drug Administration (FDA).
Aduhelm is supplied as injections containing a dose of 100mlg. The drug is prescribed to patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) by reducing amyloid beta plaques in the brain.
On the occasion, Rachid Azar, Executive Vice President, Alzheimer’s and Cognitive Impairment Business Unit, said: “We believe that this drug will give patients with early-stage Alzheimer’s disease, their families, and healthcare providers a new glimmer of hope, especially as they have been waiting for scientific progress in this regard for decades.
Azar extended his thanks to the UAE’s Ministry of Health for its efficient response to the unmet needs of Alzheimer’s patients and its rapid evaluation of the Aduhelm drug.
The efficacy of Aduhelm was 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 assessed in the double-blind, randomized, placebo-controlled, dose-ranging Phase 1b 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 achievement by moving beyond treating the symptoms of Alzheimer’s disease towards targeting its main causes. Early detection and diagnosis of MCI will allow us to identify patients who may benefit from this innovative treatment.”
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