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Baxfendy has been approved by the US Food and Drug Administration as a first-in-class aldosterone synthase inhibitor for the treatment of hypertension in combination with other blood pressure-reducing drugs in adults who are not adequately controlled. The drug works by inhibiting the production of aldosterone, a hormone that raises blood pressure to unhealthy levels.
Approval was based on positive results from the BaxHTN phase III trial, AstraZeneca said.
Ruud Dobber, executive vice president at AstraZeneca’s biopharmaceuticals business unit, said: "The approval of Baxfendy offers a much-needed, first-in-class innovation for people living with persistently uncontrolled hypertension.
“In the US, about 23m patients are uncontrolled despite being on two or more medicines for hypertension, which is a disease that has seen little therapeutic progress for the past two decades."
Cardiovascular, renal and metabolism, part of the biopharmaceuticals unit, is one of AstraZeneca’s key disease areas and growth drivers. The London-listed firm acquired Baxfendy when it bought CinCor Pharma for up to $1.8bn in early 2023.
AstraZeneca also announced on Monday that Enhertu had been approved by the FDA for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer, based on results from phase III trials. The drug is being jointly developed by AstraZeneca and Japan’s Daiichi Sankyo.
Dave Fredrickson, executive vice president at AstraZeneca’s oncology haematology business unit, said: "HER2-positive early disease is considered highly curable. However, up to one in four patients still experience disease recurrence, underscoring the need for new options in this setting.
"These approvals mark an important step forward, expanding the possibility of cure to more patients for the first time in many years, and positioning Enhertu as a foundational treatment in early breast cancer."
As at 0845 BST, shares in AstraZeneca were off 1% at 13,546p.
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