AstraZeneca’s Baxfendy (baxdrostat) has moved a step closer to European Union (EU) approval after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the drug for adults with arterial hypertension that remains inadequately controlled despite treatment with at least two antihypertensive medicines.

 

If approved, Baxfendy would become the first and only aldosterone synthase inhibitor (ASI) available in the EU, introducing a new treatment approach that directly targets aldosterone, a hormone that plays a key role in driving high blood pressure.

 

The positive CHMP opinion is backed by two pivotal Phase III trials, in which Baxfendy delivered statistically significant and clinically meaningful reductions in blood pressure among patients with uncontrolled or resistant hypertension. The studies demonstrated reductions in seated systolic blood pressure (SBP), as well as 24-hour average ambulatory SBP in patients with resistant hypertension.

 

The recommendation comes against the backdrop of a growing global hypertension crisis. An estimated 1.4 billion people worldwide are living with the condition, while approximately 50% of patients taking two or more blood pressure medications continue to struggle with inadequate control.

 

In Europe alone, around 70 million adults have hypertension that remains uncontrolled despite treatment, leaving them at increased risk of cardiovascular disease and premature death.

 

Hypertension remains the world's most prevalent and significant modifiable cardiovascular risk factor, accounting for more deaths and disability than any other modifiable risk.8-10 Elevated aldosterone levels are a key contributor to persistently uncontrolled hypertension and have also been linked to declining kidney function and increased cardiovascular risk.

 

DBryan Williams, Chair of Medicine at University College London and primary investigator for BaxHTN and Bax24, said: "The strength of the research behind Baxfendy is a triumph of science and demonstrates its potential as an important new class of treatment for people in Europe living with persistently uncontrolled hypertension. 

 

"Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events like heart attack and stroke, underscoring why effective blood pressure lowering matters for people living with uncontrolled hypertension."

 

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: "Hypertension is often called the 'silent killer' and is a leading risk factor for heart attack, stroke and dementia. This positive CHMP opinion for Baxfendy marks a significant step toward bringing this potential first-in-class innovation to patients in Europe. This novel medicine reflects the strength of our pipeline across interconnected cardiovascular, renal and metabolic diseases as we deliver on our 2030 ambition to bring 20 new medicines to the world."

 

The positive regulatory recommendation is supported by findings from the BaxHTN and Bax24 Phase III trials, both of which demonstrated meaningful blood pressure reductions when Baxfendy was added to standard treatment.

 

In the BaxHTN Phase III trial,14 published in the New England Journal of Medicine,1 Baxfendy significantly reduced blood pressure in patients with hypertension who were already receiving standard-of-care treatment.

 

Baxfendy was generally well-tolerated across both trials, with no unanticipated safety findings.

 

Unlike conventional blood pressure treatments, Baxfendy is designed to target the production of aldosterone directly. The highly selective and potent ASI inhibits the production of the hormone, which can drive blood pressure to unhealthy levels and increase the risk of heart and kidney complications.

 

The drug is already approved in the US and other countries as a first-in-class ASI for adults whose hypertension is not adequately controlled with other therapies. Regulatory applications are also under review in other major markets, including Japan and China.

 

An EU approval would mark another major regulatory milestone for AstraZeneca and potentially expand treatment options for patients who continue to face high blood pressure despite taking multiple medications.