In a landmark regulatory achievement, the UAE's Emirates Drug Establishment has approved “Tolebrutinib” as the world’s first oral treatment for non-relapsing secondary progressive multiple sclerosis (SPMS).

 

This milestone underscores the nation’s commitment to providing advanced, science-based therapeutic solutions that enhance patients’ quality of life and align with global healthcare advancements, said a Wam news agency report.

 

The approval 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, improving care quality for MS patients in the UAE.

 

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.

 

Dr Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, emphasisd 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."