UAE becomes first country to approve innovative hypertension drug Baxfendy

Emirates Drug Establishment has announced the approval of the innovative drug “Baxfendy,” containing the active ingredient “Baxdrostat,” developed by AstraZeneca.

The medication, available in 1mg and 2mg doses, is used as an additional treatment alongside blood pressure-lowering medications for patients whose blood pressure levels cannot be adequately controlled.

The UAE is the first country in the world to grant approval for this treatment, reflecting its continued commitment to accelerating access to pharmaceutical innovations and enabling their adoption through flexible regulatory frameworks that support innovation and speed up the approval of advanced therapies. This aligns with developments in the healthcare sector and enhances pharmaceutical care efficiency, particularly in the field of cardiovascular diseases.

“Baxfendy” helps lower blood pressure by inhibiting an enzyme responsible for producing the hormone aldosterone in the body, offering a therapeutic approach that targets the root causes of the condition, especially among patients suffering from uncontrolled hypertension despite conventional treatments.

Dr Fatima Al Kaabi, Director General of the Emirates Drug Establishment, said: “The approval of this treatment marks a significant step reflecting the UAE’s direction toward enabling advanced medical solutions that precisely target disease mechanisms, particularly in cases that do not respond to traditional treatment options, while ensuring uninterrupted availability for patients.”

She added: “At the foundation, we focus on accelerating approval and accessibility procedures through a flexible regulatory approach linked to national health priorities, ensuring these solutions reach patients at the right time and achieve a tangible impact on treatment outcomes. This also strengthens the readiness of the healthcare system to efficiently and sustainably manage chronic diseases, positively impacting quality of life and community wellbeing.”

Meanwhile, Sameh El Fangary, President of AstraZeneca Gulf, said: “The approval of Baxfendy in the UAE marks an important milestone in the development of innovative treatments for hypertension and reflects regulatory confidence in the scientific data supporting this therapy. We look forward to contributing to improved patient treatment outcomes.”

He added: “We remain committed to working with partners in the UAE to ensure access to pharmaceutical innovations for patients and contribute to improving long-term healthcare outcomes.”

The approval of “Baxfendy” 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 levels when used alongside standard treatments.

Hypertension remains one of the major health challenges in the UAE, with estimates indicating that nearly one in three adults suffers from the condition, making it one of the most widespread non-communicable diseases. Despite the availability of multiple treatment options, disease control rates remain below desired levels.

The approval comes as part of the Emirates Drug Establishment’s efforts to strengthen pharmaceutical security and ensure the sustainable availability of innovative treatments, enhancing market stability and continuity of supplies. It also contributes to improving the efficiency and preparedness of the pharmaceutical system, in line with national goals to build a resilient and sustainable healthcare ecosystem that supports public health.