AstraZeneca to Seek Approval for Blood Pressure Drug Baxdrostat

AstraZeneca plans to apply for regulatory approval for Blood Pressure Drug Baxdrostat before the end of this year, with approval expected in the U.S. and E.U. in 2026.

The company views the opportunity in Baxdrostat as the crux of its strategy for long-term growth, according to Ruud Dobber, president of AstraZeneca's biopharmaceuticals unit.

Baxdrostat represents a new approach to the treatment of hypertension in that it acts by reducing aldosterone, a hormone that regulates blood pressure, as opposed to several older antihypertensive therapies such as ACE inhibitors and diuretics which do not address the hormonal aspect of hypertension. AstraZeneca estimates peak annual sales of more than $5 billion for the drug.

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In late-stage trial results released this week, Baxdrostat reduced systolic blood pressure when added to standard care by 9.8 mmHg at 2mg after 12 weeks compared to placebo, and 8.7 mmHg at 1mg.

While physicians have said that a 10-12 mmHg decline would be an ideal outcome for their patients, he said they were not unsatisfied with the decline and it was consistent with their expectations, particularly when compared to a competitor, Mineralys Therapeutics' therapy, lorundrostat, which achieved a 9.1 mmHg drop in systolic blood pressure with a 50mg dose in a six-week study.

Safety data indicated that only 1.1% of patients on Baxdrostat experienced hyperkalemia, which refers to high potassium levels and has also been reported as a side effect of lorundrostat. With high blood pressure affecting more than a billion people worldwide, AstraZeneca is excited about prospects for the drug ahead, especially as the industry emphasizes more aggressive options for hypertension management.