First-in-world approval aims to tackle root causes of resistant high blood pressure

The UAE has become the first country in the world to approve AstraZeneca’s innovative hypertension treatment Baxfendy, as part of its efforts to accelerate access to advanced medicines and strengthen cardiovascular care.
The Emirates Drug Establishment (EDE) said the treatment, which contains the active ingredient Baxdrostat, was approved in 1 mg and 2 mg doses as an additional therapy for patients whose blood pressure remains uncontrolled despite conventional treatment.
The drug works by inhibiting an enzyme responsible for producing aldosterone, a hormone linked to elevated blood pressure, offering what officials described as a treatment approach targeting the root causes of uncontrolled hypertension.
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The approval was based on positive results from two Phase III clinical trials, BaxHTN and Bax24, which showed statistically significant reductions in uncontrolled blood pressure when used alongside standard therapies.
Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said the approval reflected the UAE’s strategy to accelerate access to advanced medical solutions through a flexible regulatory framework.
Sameh El Fangary, Gulf Cluster President at AstraZeneca Gulf President, said the approval marked a significant step in the development of innovative treatments for hypertension and highlighted confidence in the scientific data supporting the therapy.
Hypertension remains one of the UAE’s most widespread chronic health conditions, with estimates suggesting around one in three adults in the country is affected, despite the availability of multiple treatment options.