Approval of Rilzabrutinib in the UAE
The Emirates Drug Establishment (EDE) has granted official approval for Rilzabrutinib, the first oral Bruton’s tyrosine kinase (BTK) inhibitor authorised in the UAE for treating Immune Thrombocytopenia (ITP), a rare autoimmune disorder affecting 2 to 5 individuals per 100,000 worldwide.
Global Leadership in Medical Innovation
With this landmark approval, the UAE leads globally in accelerating access to advanced treatments and addressing critical medical needs, becoming the first country to authorise this innovative medication.
Significance of Rilzabrutinib Approval
Rilzabrutinib offers ITP patients early access to a pioneering therapeutic solution that improves treatment journeys and quality of life. Developed by Sanofi, it targets the underlying cause of ITP by increasing platelet counts, thus addressing symptoms and root causes. Clinical studies show promising results, with substantial improvement in health indicators.
Strategic Commitment of the UAE
The approval aligns with the UAE’s commitment to providing high-efficacy treatments aligned with international standards. Dr. Fatima Al Kaabi, Director-General of the EDE, highlighted the UAE’s role as a pharmaceutical hub, emphasizing healthcare innovation and flexible regulatory systems.
“The Emirates Drug Establishment will spare no effort to accelerate regulatory procedures and strengthen global partnerships,” she said.
Collaborative Efforts
Preeti Futnani, MCO Lead and General Manager at Sanofi, expressed collaboration with the EDE to deliver groundbreaking treatment to UAE patients, underscoring a shared commitment to meeting unmet medical needs.
