A new blood pressure medication has cleared regulatory approval in the UAE, making the country the first in the world to authorize AstraZeneca’s Baxfendy for clinical use.
The Emirates Drug Establishment approved the drug — which contains the active ingredient Baxdrostat — in 1 mg and 2 mg doses, indicated as an add-on therapy for patients whose hypertension remains poorly controlled despite existing treatments.
Sameh El Fangary, Gulf Cluster President at AstraZeneca, said the milestone underscored broader confidence in the scientific evidence behind the drug. “The approval marked a significant step in the development of innovative treatments for hypertension and highlighted confidence in the scientific data supporting the therapy,” he said.
Baxfendy targets aldosterone, a hormone that contributes to elevated blood pressure, by blocking the enzyme involved in its production. The mechanism is distinct from standard antihypertensives, positioning it as an option for patients who have not responded adequately to conventional regimens.
The EDE’s decision drew on data from two Phase III trials — BaxHTN and Bax24 — both of which recorded statistically significant drops in blood pressure when Baxfendy was administered alongside standard-of-care medications.
Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said the approval was consistent with the UAE’s regulatory approach. “The approval reflected the UAE’s strategy to accelerate access to advanced medical solutions through a flexible regulatory framework,” she said.
Hypertension is estimated to affect roughly one in three adults in the UAE, making it one of the country’s most prevalent chronic conditions despite the range of treatments already on the market.
