UAE first globally to approve new hypertension drug baxfendy

Treatment targets uncontrolled hypertension

The treatment, available in 1 mg and 2 mg doses, is indicated as an add-on therapy alongside antihypertensive medications for patients whose blood pressure remains inadequately controlled despite existing treatment options.

UAE becomes first country to authorise Baxfendy

With this approval, the UAE becomes the first country globally to authorise this treatment, reinforcing its commitment to ensuring timely access to pharmaceutical innovations and accelerating the adoption of advanced therapies within flexible regulatory frameworks.

How Baxfendy works

Baxfendy lowers blood pressure by inhibiting an enzyme responsible for aldosterone production, offering a targeted approach that addresses underlying disease mechanisms, particularly for patients with resistant hypertension.

EDE highlights commitment to innovation and patient access

“Approving this treatment is yet another significant step towards enabling advanced medical solutions,” said Dr Fatima Al Kaabi, Director-General of the EDE, adding that the authority is committed to fast-tracking access to innovative therapies to improve clinical outcomes and quality of life.

AstraZeneca welcomes UAE approval

Sameh El Fangary, Gulf Country President at AstraZeneca, said the approval reflects strong confidence in the scientific evidence behind the therapy and will help expand treatment options for hypertension patients in the UAE.

Clinical trial results and regulatory significance

The approval was based on Phase III clinical trials (BaxHTN and Bax24), which showed significant and clinically meaningful reductions in uncontrolled blood pressure when used alongside standard treatments.

Strengthening pharmaceutical security and healthcare readiness

The decision supports EDE’s efforts to enhance pharmaceutical security, ensure sustainable access to innovative treatments, and strengthen the healthcare system in line with national priorities.