AstraZeneca Hypertension Treatment Baxfendy Approved by FDA

The U.S. FDA approved AstraZeneca’s Baxfendy (baxdrostat) for the treatment of hypertension in adults who are not adequately controlled.

Hypertension is the most prevalent and significant modifiable cardiovascular risk factor in the world, according to AstraZeneca. However, it accounts for more deaths and disability than any other modifiable risk.

How Baxfendy Helps Hypertension

AstraZeneca says Baxfendy is a first-in-class, highly selective and potent aldosterone synthase inhibitor (ASI). The CYP11B2 gene encodes aldosterone synthase, an enzyme. In turn, this gene synthesizes aldosterone in the adrenal gland. As a hormone that raises blood pressure to unhealthy levels, aldosterone increases risk of heart and kidney problems.

The FDA’s approval of Baxfendy is for use in combination with other antihypertensive medications. In the U.S., approximately 50% of patients with hypertension already take multiple antihypertensive medicines, yet struggle with elevated blood pressure.

AstraZeneca Runs the Numbers

According to AstraZeneca Executive Vice President, BioPharmaceuticals Business Unit Ruud Dobber, approximately 23 million U.S. patients have uncontrolled hypertension. He said hypertension has seen little therapeutic progress in the last two decades.

“The approval of Baxfendy offers a much‑needed, first-in-class innovation for people living with persistently uncontrolled hypertension,” Dobber said.

FDA Looked at Positive Trial Results

In a Phase III trial (BaxHTN), Baxfendy demonstrated statistically significant, clinically meaningful seated systolic blood pressure reduction. Patients received the treatment in 2mg and 1mg doses; this grouping had uncontrolled, resistant hypertension, on two or more medications.

The results of this trial led to the FDA approval. The results were since published in the New England Journal of Medicine.

“We have been waiting for an innovative medication like Baxfendy for hypertension for many years,” added Bryan Williams, MD. Williams is Chair of Medicine at University College London and BaxHTN primary investigator. “The nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients. Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.”