UAE becomes first country to approve ‘Tolebrutinib’ for SPMS

A groundbreaking step for MS treatment

Tolebrutinib is now the only available therapy that directly targets disability progression in SPMS regardless of relapses. The decision to approve the drug followed scientific research conducted in collaboration with the National Multiple Sclerosis Society, supporting a data-driven regulatory process focused on patient care.

How Tolebrutinib works

Developed as a central nervous system-targeting oral inhibitor, Tolebrutinib focuses on B cells and microglia, two immune cells believed to drive disease progression. By reducing chronic neuroinflammation, the treatment represents a first-of-its-kind approach that addresses the root cause of disability accumulation independent of relapse activity.

Statement from the Emirates Drug Establishment

Dr Fatima Al Kaabi, Director-General of the EDE, said the approval reflects the UAE’s commitment to fostering flexible and innovation-friendly regulations that enable rapid access to life-changing treatments.

She stated, “The approval of Tolebrutinib marks a transformative step in addressing one of the most complex neurological diseases. We are dedicated to adopting a forward-thinking approach rooted in innovation and global partnerships.”

International collaboration driving innovation

This achievement was made possible through strong collaboration between EDE and international scientific bodies, including the National Multiple Sclerosis Society. The success reflects the UAE’s readiness to adopt cutting-edge therapies and fast-track access in areas of high medical need.

Reinforcing the UAE’s global leadership in health innovation

The EDE highlighted that this approval reinforces the UAE’s leadership in bridging science and patient care, offering hope to individuals suffering from progressive MS. It also demonstrates the nation’s strategic focus on national health security and commitment to international healthcare standards.