AstraZeneca notches key FDA nod in hypertension, with an approval sweetener for Fasenra too

AstraZeneca has received a key FDA nod for its new hypertension drug Baxfendy (baxdrostat), marking the first approval of an aldosterone synthase inhibitor for high blood pressure in the United States. This decision boosts AstraZeneca's pipeline in cardiovascular disease and supports its 2030 revenue target of $80 billion. The approval is based on Phase 3 BaxHTN trial data showing statistically significant reductions in systolic blood pressure when used in combination with other antihypertensives in patients with uncontrolled or treatment‑resistant hypertension.

Concurrently, the FDA has extended an existing approval for AstraZeneca's asthma biologic Fasenra (benralizumab). The agency has cleared an expanded label or new use for Fasenra, reinforcing its role in eosinophilic diseases and broadening its eligible patient population. This dual FDA activity provides a "sweetener" for the company, pairing a novel hypertension product with an incremental gain for an established respiratory asset.

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[PDF] Reference ID: 5447728 - accessdata.fda.gov

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