The UAE has become the world's second country that approves the registration and use of the Biogen's Aduhelm (aducanumab), the first and only drug for the treatment of early stages of Alzheimer’s disease after having been approved by the Food and Drug Administration (FDA), announced the Ministry of Health and Prevention (MoHAP).

This step allows patients with Alzheimer’s disease in the UAE and regional countries to have early access to this innovative drug, resulting in the acceleration of their treatment plan and improvement of the quality of their life.

This comes as part of the UAE's global leadership in attracting and providing innovative drugs that have proven to be effective and efficient to be incorporated into treatment protocols, which contributes to the development of the health system as per best international standards.

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.

The medicine registration comes in the wake of the application of MoHAP’s innovative mechanism for its accelerators to evaluate and approve the world’s breakthrough drugs in accordance with the Fast Track / Accelerate Process system. This is coupled with the emphasis on the importance of the early diagnosis and development of medical practices related to Alzheimer's to achieve social and psychological empowerment.

Leadership in health

His Excellency AbdulRahman bin Mohammed Al Owais, Minister of Health & Prevention, stated that this significant milestone is pursuant to the directives of the wise leadership to enhance the UAE's leading position in attracting and providing drugs that have proven to be effective and efficient to be incorporated into treatment protocols.

Al Owais noted that the flexibility of supply chains and the enactment of legislations that keep pace with developments in the pharmaceutical industry greatly contribute to speeding up patient's recovery and improving their quality of life which is a top priority for the ministry and other health authorities.

The Health Minister indicated that the UAE is among the world's fastest countries in terms of granting approvals for innovative drugs, which increases the healing chances of patients in the UAE and the region.

This contributes to strengthening the state's competitiveness in the global pharmaceutical market so as to become a major destination for global pharmaceutical companies and a hub for marketing their innovative drugs.

Such an approach contributes to enhancing the efficiency of the pharmaceutical system and establishing quality and safety systems for therapeutic, health and pharmaceutical safety in line with the vision of the UAE Centennial, Al Owais said in conclusion.

Early access to innovative drugs

His Excellency Dr. Mohammed Salim Al Olama, Undersecretary of the Ministry of Health and Prevention, and Chairman of the Board of Directors of the Emirates Health Service (EHS), underlined the ministry's keenness to ensure early access to innovative medicines by facilitating the licensing procedures according to a specific mechanism for drug evaluation and registration and providing training and guidelines for physicians on appropriate use, in order to make remarkable progress in health care and provide innovative therapeutic options.  

Al Olama underscored MoHAP's commitment to providing therapeutic and psychological services to people with Alzheimer's disease, especially for the elderly over 65 years old, as they are the high-risk groups.

These services include specialized clinics, providing a supportive and stimulating environment for patients, and community rehabilitation, he explained.

This comes as part of national mental health policy strategy to achieve social, psychological and occupational empowerment of patients and provide reinforced, treatment and rehabilitation services of international standards.

Promoting pharmaceutical innovation and attracting foreign investments

The Ministry has an advanced mechanism in licensing and registering medicines in accordance with the best international standards and requirements in pharmacological evaluation, said His Excellency Dr. Amin Hussein Al Amiri, Assistant Undersecretary for the Health Regulatory Sector, adding that this contributes to strengthening the UAE's leadership in adopting the latest pharmaceutical technologies to protect community health.

He indicated that these mechanisms constitute a roadmap full of opportunities and challenges, stressing that the ministry, in cooperation with the various concerned authorities, works on updating regulatory standards, licensing mechanisms and guidelines to support pharmaceutical and health technology companies.

Al Amiri explained that the UAE has stimulating factors to invest in the pharmaceutical sector such as the advanced infrastructure and modern systems, which encourage global companies to enhance their status in the region and produce their innovative and similar medicines.

He concluded by lauding the unwavering support of the UAE government for innovation, protection of intellectual property, and encouragement of investment in the health sector and particularly the pharmaceutical one.

He emphasized that the ministry is proactively working to communicate with international companies for medicine and medical supplies to learn about the latest medical innovations, even if they are under clinical studies, to bring them to the UAE and become the first country in the world to make the most of which after being accredited by the US Food and Drug Administration (FDA).

A new glimmer of hope

On this occasion, Rachid Azar, Executive Vice President, Alzheimer’s and Cognitive Impairment Business Unit, said: "Biogen's tireless research efforts and dedication to achieving its goals have enabled us to fulfill our commitment to provide the first treatment of its kind in many years to Alzheimer's patients. 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.

Besides the provision of "Aduhelm" in the UAE in the coming months, Biogen is committed to working closely with stakeholders and decision-makers in the country to ensure broad access to Alzheimer's patients who are eligible for using this innovative drug. It is worth mentioning that Alzheimer's disease greatly affects many people all over the world.

Clinical trials

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 ADUHELM 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.”