The Emirates Drug Establishment (EDE) has approved Baxfendy, an innovative medicine developed by AstraZeneca for the treatment of uncontrolled hypertension, making the UAE the first country in the world to authorise the therapy.
Baxfendy contains the active substance baxdrostat and will be available in 1 mg and 2 mg doses. The treatment is designed as an add-on therapy for patients whose blood pressure remains inadequately controlled despite existing antihypertensive medications.
The approval reinforces the UAE’s position as a global hub for healthcare innovation and highlights the country’s commitment to accelerating patient access to advanced pharmaceutical treatments through flexible and innovation-driven regulatory frameworks.
Baxfendy works by inhibiting an enzyme responsible for aldosterone production, offering a targeted treatment approach that addresses the underlying mechanisms of resistant hypertension. The therapy is expected to benefit patients who do not respond adequately to conventional blood pressure treatments.
“Approving this treatment is yet another significant step towards enabling advanced medical solutions that precisely target disease pathways, particularly in cases that do not respond to traditional options, while ensuring uninterrupted access for patients,” said Dr. Fatima Al Kaabi, Director-General of the EDE.
She added that the EDE remains focused on accelerating approval and access pathways through flexible regulatory systems aligned with national healthcare priorities. According to her, the approach ensures timely patient access to innovative therapies while improving clinical outcomes and strengthening the healthcare system’s preparedness to address chronic diseases sustainably.
Sameh El Fangary, Gulf Country President at AstraZeneca, said, “The UAE’s approval of Baxfendy marks a significant step forward in expanding treatment options for hypertension and reflects strong confidence in the scientific evidence supporting the therapy. We look forward to improving outcomes for patients.”
He also reaffirmed the company’s commitment to collaborating with healthcare stakeholders across the UAE to expand access to pharmaceutical innovation and support long-term improvements in treatment outcomes.
The approval was supported by positive results from the Phase III BaxHTN and Bax24 clinical trials, which demonstrated statistically significant and clinically meaningful reductions in uncontrolled blood pressure when Baxfendy was used alongside standard therapies.
The move forms part of the EDE’s broader efforts to strengthen pharmaceutical security, ensure sustainable access to innovative medicines, and enhance the resilience and preparedness of the UAE healthcare ecosystem in line with national public health priorities.
With inputs from WAM
