UAE Becomes First Country To Approve Rilzabrutinib For Immune Thrombocytopenia Treatment

The Emirates Drug Establishment (EDE) has approved Rilzabrutinib, the first oral Bruton’s tyrosine kinase (BTK) inhibitor for Immune Thrombocytopenia (ITP) treatment in the UAE. This rare autoimmune disorder affects 2 to 5 people per 100,000 globally. The UAE is the first nation to authorise this medication, showcasing its leadership in providing advanced treatments and addressing urgent medical needs.

Developed by Sanofi, Rilzabrutinib marks a significant advancement in restoring immune balance by targeting ITP's root cause. It increases platelet counts, addressing both symptoms and underlying issues. Clinical trials have shown promising results, with patients experiencing notable health improvements.

The approval aligns with the UAE's strategy to ensure high-efficacy treatments meet international standards. This decision offers ITP patients early access to innovative therapy, enhancing their treatment journey and quality of life. The UAE is committed to making advanced medications available swiftly.

Dr. Fatima Al Kaabi, Director-General of EDE, 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 highlighted that this milestone reflects the UAE's effective healthcare policies and flexible regulations that encourage innovation and patient access to advanced drugs. "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 that approving Rilzabrutinib reaffirms EDE's dedication to fast-tracking transformative therapies for rare and chronic diseases. EDE aims to maintain an innovation-driven approach through international collaboration, ensuring safe and effective treatments are accessible nationwide according to global standards.

Collaborative Efforts with Sanofi

Preeti Futnani from Sanofi expressed honour in collaborating with EDE to introduce this treatment for ITP patients in the UAE. "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," she said.

This approval underscores the UAE's proactive stance on healthcare advancements amid rapid scientific progress. The focus remains on enhancing health system readiness while ensuring transformative therapies are available across the country.

With inputs from WAM