The Emirates Drug Establishment (EDE) has approved Baxfendy, an innovative medicine containing the active substance baxdrostat, developed by AstraZeneca.
The treatment, available in 1 mg and 2 mg doses, is indicated as an add-on therapy alongside antihypertensive medications for patients whose blood pressure remains inadequately controlled despite existing treatment options.
With this approval, the UAE becomes the first country globally to authorise this treatment, reinforcing its commitment to ensuring timely access to pharmaceutical innovations and enabling their adoption within flexible regulatory frameworks that support innovation and accelerate the approval of advanced therapies. This, in turn, keeps pace with sector developments and enhances the efficiency of pharmaceutical care, particularly in cardiovascular diseases.
Baxfendy lowers blood pressure by inhibiting an enzyme responsible for aldosterone production, offering a targeted approach that addresses underlying disease mechanisms. It is particularly relevant for patients with resistant hypertension who do not respond adequately to conventional 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 EDE is committed to accelerating approval and access processes by putting in place a flexible regulatory approach aligned with national health priorities. This ensures timely patient access to innovative treatments and delivers tangible improvements in clinical outcomes.
It also strengthens the system’s readiness to address chronic diseases efficiently and sustainably, ultimately enhancing quality of life and overall community wellbeing.
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 reaffirmed the company’s commitment to working with partners across the UAE to ensure patients have access to pharmaceutical innovations and to support long-term improvements in treatment outcomes.
Baxfendy’s approval was based on positive results from two Phase III clinical trials, BaxHTN and Bax24, which demonstrated statistically significant and clinically meaningful reductions in uncontrolled blood pressure when used alongside standard therapies, said a statement.
