AstraZeneca has received approval from the Emirates Drug Establishment (EDE) in the United Arab Emirates (UAE) for Baxfendy, a medicine using the active ingredient baxdrostat, for uncontrolled hypertension.
With this authorisation, the UAE is said to become the first nation worldwide to approve this treatment, which is offered in 1mg and 2mg doses.
This move underscores its objective to provide timely access to pharmaceutical innovations and implement adaptable regulatory frameworks that facilitate innovation and expedite the approval of advanced therapies.
Baxfendy is intended for adults with hypertension that remains uncontrolled despite the use of existing antihypertensive medications.
Its mechanism of action involves inhibiting the enzyme responsible for creating aldosterone, which helps reduce blood pressure by targeting the root causes of resistant hypertension.
This offers a new therapeutic choice for patients who have an inadequate response to conventional antihypertensive agents.
AstraZeneca Gulf country president Sameh El Fangary 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.
“We are committed to working with partners across the UAE to ensure access to pharmaceutical innovation and to support long-term improvements in treatment outcomes.”
The regulatory approval is supported by data from two Phase III clinical studies, BaxHTN and Bax24, which confirmed Baxfendy’s use as an adjunct to standard therapies, demonstrating meaningful blood pressure reductions.
The EDE has indicated that the approval forms part of ongoing efforts to enhance pharmaceutical security and resilience, supporting a sustainable healthcare system in line with national priorities.
Last month, AstraZeneca received approval from the US Food and Drug Administration (FDA) for the subcutaneous self-administration of Saphnelo (anifrolumab-fnia) using the Saphnelo Pen autoinjector for systemic lupus erythematosus (SLE).
