AstraZeneca Earns US Approval for 16-Point Blood Pressure Drug and $155M Cancer Milestone
AstraZeneca won US approval for Baxfendy, a first-in-class aldosterone blocker that lowered systolic blood pressure by 16 points at higher doses in trials for uncontrolled hypertension. Regulators also approved Enhertu for early-stage HER2-positive breast cancer, triggering $155 million in milestone payments.
1. US Approval of Baxfendy
AstraZeneca secured US approval for Baxfendy, the first new class of hypertension drug in over 20 years. The aldosterone blocker targets patients with persistently uncontrolled blood pressure who have not responded to existing therapies.
2. Baxfendy Trial Efficacy and Market Potential
In phase III trials, Baxfendy at higher doses reduced systolic blood pressure by nearly 16 points, with a 10-point reduction attributable specifically to the drug versus placebo. This level of improvement corresponds to a roughly 20% lower risk of serious cardiovascular events per 10-point drop and underpins potential multibillion-dollar peak sales.
3. Enhertu Expanded Early-Stage Approval
US regulators approved Enhertu for pre- and post-surgery treatment of early-stage HER2-positive breast cancer, cutting the risk of recurrence or death by 53% compared with existing therapy. This label expansion triggers $155 million in milestone payments and extends Enhertu’s use into both curative and advanced disease settings.