Saudi Food and Drug Authority Approves BAXFENDY™ (baxdrostat) for Adults with Uncontrolled and Resistant Hypertension

New treatment option for adults living with uncontrolled and resistant hypertension in Saudi Arabia

RIYADH, Saudi Arabia - The Saudi Food and Drug Authority (SFDA) has approved AstraZeneca's BAXDROSTAT as an add-on therapy for the treatment of hypertension in adult patients whose blood pressure is not adequately controlled despite treatment with two antihypertensive medications (uncontrolled hypertension), or with three or more antihypertensive medications (resistant hypertension).

The approval introduces a new treatment option for adults living with uncontrolled and resistant hypertension and supports ongoing efforts to improve access to innovative cardiovascular medicines in Saudi Arabia.

A Substantial National Burden

The World Health Organization estimates that 30% of adults aged 30-79 years in Saudi Arabia had hypertension in 2024, representing approximately 6.1 million people. Approximately 4.7 million of them did not have their blood pressure controlled, highlighting a significant unmet need in hypertension management.

The consequences of uncontrolled hypertension extend well beyond elevated blood pressure. According to the WHO Global Hypertension Report, 53% of cardiovascular mortality worldwide is attributable to elevated systolic blood pressure, while 58% of stroke deaths are linked to high systolic blood pressure, underscoring the critical importance of improving blood pressure control to reduce cardiovascular risk and prevent premature mortality.

Saudi Arabia is addressing non-communicable diseases through the Health Sector Transformation Program under Saudi Vision 2030, with a shift toward prevention and long-term health. Hypertension is a priority within this transformation because it is highly prevalent and has modifiable risk factors.

A New Mechanism for Uncontrolled Hypertension

BAXDROSTAT is an oral aldosterone synthase inhibitor that reduces aldosterone production, a biological pathway involved in blood-pressure regulation. In the phase 3 BaxHTN trial, BAXDROSTAT was evaluated as an add-on to existing antihypertensive therapy in adults with uncontrolled or resistant hypertension.

Hatem Werdany, Country President, AstraZeneca Saudi Arabia: “Hypertension remains a major public-health challenge in Saudi Arabia, with millions of adults living with blood pressure that is not controlled. The approval of BAXDROSTAT brings a new treatment option with a novel mechanism of action for appropriate patients living with uncontrolled or resistant hypertension. We are proud to bring this innovation to Saudi Arabia and hopeful that it will provide healthcare professionals with an additional option to help address one of the country's most significant cardiovascular health challenges"

AstraZeneca remains committed to working with partners across Saudi Arabia's healthcare ecosystem to support hypertension awareness, earlier detection and appropriate access to innovative treatments.

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