- Baxdrostat shows meaningful drop in blood pressure
- Regulatory filing expected by year end
- Targeting $5 billion annual sales
Pharmaceutical giant AstraZeneca (AZN) said it plans to file for regulatory approval of its experimental blood pressure treatment baxdrostat before the end of 2025 after it showed positive results in a late-stage clinical trial.
The shares ticked up 1% to £118.84, taking year-to-date gains to 12%, in line with the return of the FTSE 100 index.
STRONG EFFICACY
The BaxHTN phase three clinical trial showed baxdrostat demonstrated a statistically significant and clinically meaningful reduction in systolic blood pressure and a favourable safety profile, in patients with hard-to-treat hypertension.
The trial met all confirmatory secondary endpoints including a durable long-term reduction in blood pressure.
Sharon Barr, Executive Vice President, BioPharmaceuticals research and development, said: ‘The BaxHTN Phase III results demonstrate baxdrostat’s potential in tackling one of the toughest challenges in cardiovascular care, which is hypertension that is hard to control despite multiple therapies.’
Unlike existing treatments baxdrostat targets aldosterone, one of the hormones which drives elevated blood pressure and increased cardiovascular risk.
There are 1.3 billion people worldwide living with hypertension and roughly half of US patients on multiple treatments do not have their blood pressure under control, the company said.
$5 BILLION BLOCKBUSTER
AstraZeneca is aiming for potential approvals in 2026 across the US and European Union and estimates the novel treatment has the potential for peak annual sales of more than $5 billion.
Analyst Luisa Hector at Berenberg believes the market opportunity for baxdrostat is $6 billion, comprised of $3 billion as a monotherapy and $3 billion as a combination therapy.
‘Baxdrostat reduced blood pressure by a compelling 9.8mmHg in treatment resistant/uncontrolled hypertension patients.
‘Our confidence has increased in monotherapy launch and a successful phase three trial for baxdrostat+Farxiga in patients with hypertension and kidney disease / heart failure,’ said Hector.
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