UAE becomes first country to approve Rilzabrutinib for rare autoimmune disorder Immune Thrombocytopenia (ITP)

Abu Dhabi:  The UAE has become the first country in the world to approve Rilzabrutinib, a breakthrough oral therapy for Immune Thrombocytopenia (ITP) — a rare autoimmune disorder that affects between two and five people per 100,000 globally.

The approval, granted by the Emirates Drug Establishment (EDE), marks a major advancement in ITP treatment and underscores the UAE’s leadership in pharmaceutical innovation and fast-tracking access to high-impact therapies.

Rilzabrutinib is the first oral Bruton’s tyrosine kinase (BTK) inhibitor approved in the UAE for ITP — a condition where the immune system mistakenly attacks platelets, increasing the risk of bruising and bleeding.

Developed by global healthcare company Sanofi, the drug targets the underlying immune dysfunction and has shown promising results in clinical trials, improving platelet counts and patient quality of life.

“This approval represents a crucial step in our mission to fast-track access to transformative therapies,” said Dr. Fatima Al Kaabi, Director-General of the EDE. “It reflects the UAE’s strategy to enhance pharmaceutical security, adopt cutting-edge treatment protocols, and strengthen its position as a regional hub for pharmaceutical excellence.”

Dr. Al Kaabi also highlighted the UAE’s flexible, innovation-driven regulatory approach. “We remain committed to expanding access to life-saving therapies, particularly for rare and chronic diseases, in line with the highest international standards,” she added.

Rilzabrutinib rebalances immune responses by addressing the root causes of ITP rather than just managing symptoms. Its oral formulation offers patients greater convenience than conventional treatments, which often involve infusions or steroids.

Preeti Futnani, General Manager for Specialty Care at Sanofi in the Gulf region, welcomed the approval. “We are honoured to work with the Emirates Drug Establishment to bring this groundbreaking treatment to patients in the UAE. This partnership reflects our shared commitment to addressing unmet medical needs through patient-centred innovation.”

The approval reinforces the UAE’s growing role in the global pharmaceutical arena and its commitment to proactive, patient-focused healthcare policy.

The Emirates Drug Establishment affirmed its dedication to streamlining regulatory processes and enhancing international cooperation to ensure the rapid delivery of safe, effective, and advanced treatments across the country.