In a landmark regulatory achievement that reflects the UAE’s leadership in accelerating access to innovative therapies, the Emirates Drug Establishment has announced the approval of “Tolebrutinib” as the world’s first oral treatment for non-relapsing secondary progressive multiple sclerosis (SPMS) says an official statement issued on Teusday.
This milestone,the statement noted, underscores the nation’s commitment to providing advanced, science-based therapeutic solutions that enhance patients’ quality of life and align with global healthcare advancements.
The approval,it added, was based on a scientific study conducted in collaboration with the National Multiple Sclerosis Society.
Tolebrutinib is currently the only treatment that directly targets disability progression regardless of relapses, supporting evidence-based regulatory decisions and improving care quality for MS patients in the UAE.
Targeted Therapeutic Approach
Tolebrutinib was developed as an oral inhibitor that targets specific immune cells within the central nervous system, namely B cells and microglia, which are believed to play a key role in disease progression.
By addressing underlying chronic neuroinflammation, the treatment introduces a novel approach that tackles the root cause of disability accumulation independently of relapses, a breakthrough not achieved by previous therapies.
Flexible Regulatory Environment
Her Excellency Dr. Fatima Al Kaabi, Director General of the Emirates Drug Establishment, emphasized that this approval reflects the success of the UAE’s proactive policies in fostering a flexible regulatory ecosystem that supports innovation and expedites patient access to advanced treatments. She stated:
“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. We are dedicated to adopting a forward-thinking approach rooted in innovation and global partnerships, ensuring the availability of safe and effective treatment options that meet the highest international standards.”
“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. 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.”
Strategic Partnership
In this context, the partnership with the National Multiple Sclerosis Society marks a pivotal moment in the development of targeted therapies for patients with progressive MS, culminating in the approval of the first treatment to directly address the mechanisms of disability progression independent of relapses.
The adoption of this advanced scientific approach, coupled with effective collaboration, underscores the UAE’s leadership in accelerating access to scientific innovation. It also reflects the Emirates Drug Establishment’s genuine commitment to improving patients’ outcomes and expanding access to evidence-based care.
SOURCE
EMIRATES DRUG ESTABLISHMENT
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