AstraZeneca wins FDA approval for Baxfendy in hypertension, while Fasenra also gets a new U.S. use

AstraZeneca said the U.S. Food and Drug Administration has approved Baxfendy for adults with hypertension that is not adequately controlled by existing medicines.

The company described Baxfendy, also known as baxdrostat, as a first-in-class aldosterone synthase inhibitor. Coverage said the approval follows positive Phase III BaxHTN results.

The decision gives AstraZeneca a new entry in the hypertension market, where many patients still struggle to reach blood-pressure targets on current therapy.

A second regulatory win

Separate reporting said the FDA also approved Fasenra for a new U.S. use in hypereosinophilic syndrome.

That means AstraZeneca picked up two regulatory wins in the same period: a fresh approval for a potential new blood-pressure treatment and a label expansion for one of its established biologic medicines.

The company announcement and subsequent reporting did not indicate any unresolved regulatory questions around either approval.

The approvals add to AstraZeneca’s respiratory and cardiovascular franchises as it looks to expand growth beyond its larger existing products.