Emirates Drug Establishment approves AstraZeneca’s Baxfendy for uncontrolled hypertension in UAE

UAE—Emirates Drug Establishment has approved AstraZeneca’s innovative hypertension medicine Baxfendy, making the United Arab Emirates the first country in the world to authorise the treatment for adults with uncontrolled high blood pressure.

The medicine contains the active ingredient baxdrostat and will be available in 1mg and 2mg doses.

Regulators approved the drug as an additional therapy for patients whose blood pressure remains uncontrolled despite using standard antihypertensive medicines.

The approval highlights the UAE’s growing focus on accelerating access to innovative medicines through flexible regulatory pathways that speed the introduction of advanced therapies into the healthcare system.

Health officials said the move also supports the country’s broader efforts to strengthen pharmaceutical security and improve long-term healthcare resilience.

New approach targets root cause of resistant hypertension

Baxfendy works differently from many conventional blood pressure treatments. The medicine blocks the enzyme that produces aldosterone, a hormone linked to salt retention and elevated blood pressure.

By reducing aldosterone production, the therapy helps the body eliminate excess fluid, relax blood vessels, and lower blood pressure levels more effectively.

Healthcare experts described the approval as an important development for patients living with resistant hypertension, particularly those who do not respond adequately to existing therapies.

According to estimates cited by UAE authorities, nearly one in three adults in the country lives with hypertension, making it one of the region’s most widespread non-communicable diseases.

Dr. Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said the approval reflects the UAE’s commitment to enabling advanced medical solutions that target disease pathways more precisely while ensuring patients continue to receive uninterrupted access to treatment.

She added that the regulator remains focused on accelerating approvals for innovative medicines aligned with national healthcare priorities.

Sameh El Fangary, President of AstraZeneca Gulf, said the approval represents a major milestone in expanding treatment options for hypertension and demonstrates confidence in the scientific evidence supporting the therapy.

He added that the company will continue collaborating with healthcare partners across the UAE to improve patient access to pharmaceutical innovation and enhance long-term treatment outcomes.

Clinical trial data supported approval

The approval was backed by findings from the Phase III BaxHTN and Bax24 clinical studies, which demonstrated statistically significant and clinically meaningful reductions in blood pressure when Baxfendy was used alongside standard therapies.

Additional expert commentary published this week indicated that some patients previously unresponsive to conventional medications recorded response rates ranging from 40% to 70% after treatment with baxdrostat.

AstraZeneca expands global innovation pipeline

The UAE approval comes amid a series of major developments for AstraZeneca globally.

This week, the company also announced positive Phase III trial results for Imfinzi combined with enfortumab vedotin in patients with muscle-invasive bladder cancer, demonstrating significant improvements in event-free and overall survival compared with standard treatment.

Last month, AstraZeneca also secured US Food and Drug Administration approval for the self-administration version of Saphnelo, using the Saphnelo Pen autoinjector, for patients with systemic lupus erythematosus.