Key Takeaways
(Bloomberg) -- AstraZeneca PLC (LSE:AZN, NASDAQ:AZN) received US Food and Drug Administration approval for its novel hypertension drug, Baxfendy, a first-in-class treatment for patients whose blood pressure is not controlled by other medicines.
"The approval of Baxfendy is a significant milestone for the millions of Americans with uncontrolled hypertension," said a company spokesperson. "By targeting the hormonal pathway of aldosterone production, we are offering a new approach to managing this chronic condition."
In a late-stage clinical trial, a 2 mg dose of Baxfendy, when added to existing treatments, lowered systolic blood pressure by 9.8 millimeters of mercury (mmHg) at 12 weeks compared to a placebo. A 1 mg dose showed a reduction of 8.7 mmHg. The drug is also under investigation for chronic kidney disease and heart failure.
AstraZeneca acquired the drug through its $1.8 billion purchase of CinCor Pharma in February 2023 and anticipates peak annual sales could exceed $5 billion. The approval places AstraZeneca ahead of competitor Mineralys Therapeutics, which is developing a similar drug.
Baxfendy, with the generic name baxdrostat, is an aldosterone synthase inhibitor. It works by blocking the production of aldosterone, a hormone that can cause high blood pressure and increase the risk of heart and kidney damage. This mechanism differs from older treatments like diuretics and ACE inhibitors that do not address hormonal drivers of hypertension.
Hypertension is a major global health issue, affecting an estimated 1.4 billion people and being a leading cause of premature death, according to the World Health Organization. In the United States, nearly half of adults, or about 120 million people, have high blood pressure.
The approval of Baxfendy provides a new option for the significant number of patients with treatment-resistant hypertension. AstraZeneca's projection of over $5 billion in peak sales highlights the commercial potential for this new class of medication. The company's next challenge will be to secure market access and educate physicians on the novel mechanism of action. Investors will be watching the initial sales figures closely following the US launch.
This article is for informational purposes only and does not constitute investment advice.
