In a global first, the Emirates Drug Establishment (EDE) has approved Tolebrutinib, the only oral treatment specifically developed to slow disability progression in adults with non-relapsing secondary progressive multiple sclerosis (SPMS). The landmark decision positions the UAE at the forefront of neurological healthcare innovation and marks a significant step forward for people living with one of the most challenging forms of multiple sclerosis.
A new era in MS treatment
Tolebrutinib is an oral medication classified as a Bruton’s tyrosine kinase (BTK) inhibitor. It works by targeting specific immune cells in the brain and spinal cord, mainly B cells and microglia, that drive chronic inflammation and damage in multiple sclerosis (MS). Unlike previous treatments that focus on controlling flare-ups or relapses, Tolebrutinib directly addresses the ongoing inflammation responsible for disability progression, especially in the advanced stage of the disease called non-relapsing secondary progressive MS (SPMS). This makes it the first therapy designed to slow down worsening symptoms in patients whose MS no longer involves relapses.The UAE has taken a decisive step in advancing neurological healthcare with the approval of Tolebrutinib, a first-of-its-kind oral therapy for non-relapsing secondary progressive multiple sclerosis (SPMS). The approval, announced by the Emirates Drug Establishment (EDE), makes the UAE the first country in the world to authorize the use of this treatment, reinforcing its commitment to accelerating access to scientific innovation. Multiple sclerosis (MS) is a chronic disease where the immune system attacks the central nervous system, leading to a wide range of symptoms such as fatigue, mobility issues, vision problems, and cognitive decline. SPMS is a more advanced stage of MS that typically follows the relapsing-remitting phase. At this stage, patients no longer experience distinct relapses or remissions, instead, their symptoms and disability worsen steadily over time.
Scientific backing and collaborative development
The approval follows a rigorous scientific evaluation carried out in partnership with the National Multiple Sclerosis Society, a globally recognized authority in MS research. The Emirates Drug Establishment cited the collaborative study as essential to its evidence-based decision, noting that the data provided strong support for Tolebrutinib’s safety, efficacy, and therapeutic innovation. “This approval is the result of collaborative efforts between the Establishment and its international partners to support scientific innovation and translate it into real-world patient benefit,” said Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment. “At the Emirates Drug Establishment, we believe in fast-tracking regulatory processes in areas of high medical need. This achievement reaffirms the readiness of our healthcare system to keep pace with rapid scientific advancements and deliver high-quality treatments that enhance quality of life and strengthen national health security.” She also added, “The approval of Tolebrutinib marks a transformative step in addressing one of the most complex neurological diseases. It embodies our commitment to accelerating access to innovative therapies that make a real difference in patients’ lives.” The drug’s mechanism represents a novel approach in MS management. Unlike previous treatments that aimed to control acute flare-ups or relapses, Tolebrutinib is designed to intervene in the slow-burning immune activity within the brain and spinal cord. This is critical in SPMS, where symptoms worsen not because of new attacks, but due to this persistent, underlying inflammation.
The role of the Emirates Drug Establishment
The regulatory green light for Tolebrutinib also reflects the growing role of the Emirates Drug Establishment, a federal authority responsible for overseeing all medical, pharmaceutical, and healthcare products across the UAE. Formed on 29 September 2023, the EDE operates under a national mandate to regulate a broad range of products, including pharmaceuticals, medical devices, stem cells, blood derivatives, genetically modified organisms, veterinary medicines, and agricultural items. The EDE was given further structural backing when the UAE Cabinet approved the formation of its Board of Directors in December 2023. The board, appointed for a three-year term, supervises the agency’s regulatory agenda across all emirates and free zones. According to the Council of Ministers’ decree, the institution’s scope extends to almost any healthcare-related product, ensuring a unified and nationally consistent oversight mechanism. With its establishment, the EDE aims to set high regulatory standards and act as a catalyst for innovation. Its mission is not only to ensure safety and compliance but also to actively foster a collaborative healthcare ecosystem that positions the UAE as a global beacon in medical innovation.
Why Tolebrutinib matters
The approval of Tolebrutinib is more than a medical milestone; it signifies a shift in how progressive MS is approached. Until now, patients with non-relapsing SPMS had limited or no targeted options, often facing a gradual and irreversible worsening of symptoms. With this new treatment:
- Disability progression can be slowed even in the absence of relapses.
- Smoldering neuroinflammation, previously difficult to treat, is now directly targeted.
- Patients have access to a convenient oral therapy, eliminating the need for injections or infusions.
Tolebrutinib’s design as a brain-penetrant BTK inhibitor opens up a new path in managing central nervous system disorders, with possible implications for other neurodegenerative diseases in the future.
