The UAE has become the first country in the world to approve the innovative hypertension treatment “Baxfendy” (Baxdrostat), marking a major step forward in the management of uncontrolled high blood pressure and reinforcing the country’s commitment to accelerating access to advanced pharmaceutical innovations.
The newly approved treatment, authorised by the Emirates Drug Establishment, contains the active ingredient Baxdrostat and will be available in 1 mg and 2 mg doses. It is intended to be used alongside standard blood pressure-lowering medications for patients whose hypertension remains inadequately controlled despite conventional therapies.
Developed by AstraZeneca, the treatment works by inhibiting an enzyme responsible for producing aldosterone, a hormone linked to elevated blood pressure. By targeting one of the underlying biological causes of hypertension, the therapy offers a more precise treatment approach for patients with resistant or uncontrolled hypertension.
Dr Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said the approval reflects the UAE’s strategy of enabling advanced medical solutions that precisely target disease mechanisms, particularly in cases that do not respond effectively to traditional treatment options.
She added that the establishment is focused on accelerating approval and access procedures through a flexible regulatory framework aligned with national healthcare priorities, ensuring patients receive innovative therapies in a timely manner while improving treatment outcomes and supporting the sustainability of the healthcare system.
Moreover, Sameh El Fangary, President of AstraZeneca in the Gulf region, described the approval as a significant milestone in the development of innovative hypertension therapies. He noted that the decision reflects regulatory confidence in the scientific data supporting the treatment and expressed optimism about improving patient outcomes across the region.
The approval 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 Baxfendy was administered alongside standard therapies.
The move forms part of the UAE’s broader efforts to strengthen pharmaceutical security, ensure the sustainable availability of innovative medicines, and enhance the resilience and efficiency of the national healthcare system, particularly in the field of cardiovascular disease management.
