EDD approves world’s first oral therapy for immune thrombocytopenia

ABU DHABI / WAM

The Emirates Drug Establishment (EDE) has granted official approval for Rilzabrutinib, the first oral Bruton’s tyrosine kinase (BTK) inhibitor to be authorised in the country for the treatment of Immune Thrombocytopenia (ITP), a rare autoimmune disorder that affects approximately 2 to 5 individuals per 100,000 people worldwide. With this landmark approval, the UAE becomes the first country in the world to authorise this innovative medication, reflecting the nation’s global leadership in accelerating access to advanced treatments and addressing critical medical needs.
The approval of Rilzabrutinib in the UAE represents a major step forward, offering patients with ITP early access to a pioneering therapeutic solution that contributes to a faster treatment journey and a tangible improvement in quality of life. The decision aligns with the UAE’s strategic commitment to ensuring the availability of high-efficacy, globally benchmarked treatments in line with the highest international standards and protocols. Developed by global pharmaceutical and healthcare company Sanofi, Rilzabrutinib represents a breakthrough in restoring immune system balance by targeting the underlying cause of ITP. By increasing platelet counts, the treatment addresses both the symptoms and root causes of the condition. Clinical studies have demonstrated promising outcomes, with patients reporting substantial improvement in health indicators.
Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, stated, “The UAE is committed to providing access to the world’s latest therapeutic innovations and further promoting its position as a regional hub for pharmaceutical excellence. With Rilzabrutinib getting approved, we take another step further in achieving our strategy aimed at enhancing national pharmaceutical security, implementing advanced treatment protocols, and streamlining regulatory frameworks in collaboration with international partners.” Dr. Al Kaabi emphasised that the milestone demonstrates the effectiveness of the UAE’s proactive healthcare policies and flexible regulatory systems in fostering innovation and facilitating patient access to advanced medications.
“The Emirates Drug Establishment will spare no effort to accelerate regulatory procedures, and strengthen global partnerships,” she said. “This further solidifies the UAE’s role as a regional centre for pharmaceutical innovation.” She added, “Granting approval for Rilzabrutinib reaffirms the Establishment’s commitment to fast-tracking access to transformative therapies that create significant impact, particularly in the treatment of rare and chronic diseases. EDE will continue to adopt a proactive, innovation-driven approach, fuelled by international collaboration, to ensure that safe, effective therapeutic options are available across the country in accordance with the highest global standards. Our goal is to enhance the UAE’s health system preparedness in an era of rapid scientific progress.” For her part, Preeti Futnani, MCO Lead and General Manager, Specialty Care for KSA & Gulf Countries at Sanofi, said, “We are honoured to collaborate with the Emirates Drug Establishment to bring this groundbreaking treatment to patients in the UAE living with Immune Thrombocytopenia. The approval of Rilzabrutinib demonstrates our shared commitment to placing patients at the centre of our mission and delivering cutting-edge solutions that address some of the most pressing unmet medical needs.”