AstraZeneca PLC (LSE:AZN, NASDAQ:AZN) has secured US approval for Baxfendy, the first in a new class of blood pressure medication to reach the market in more than two decades.
The drug works by blocking production of aldosterone, a hormone that can raise blood pressure to dangerous levels and increase the risk of heart and kidney damage.
Roughly half of all patients in the US who take multiple blood pressure medications still cannot get their condition under control, making hypertension the leading modifiable risk factor for heart attack, stroke, kidney disease and dementia.
In clinical trials published in the New England Journal of Medicine, Baxfendy at its higher dose lowered the top blood pressure reading by nearly 16 points, with close to 10 points of that reduction attributable to the drug rather than placebo effect.
That level of improvement is considered clinically meaningful because evidence suggests every 10-point drop in the top reading is associated with a roughly 20% lower risk of serious cardiovascular events.
Ruud Dobber, executive vice president of AstraZeneca's biopharmaceuticals unit, said the drug "offers a much-needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines".
Separately, US regulators have approved two new uses for AstraZeneca and Daiichi Sankyo's breast cancer drug Enhertu, allowing it to be used for the first time in earlier-stage disease where the goal is to cure rather than manage the cancer.
Enhertu has been approved for use both before and after surgery in patients with HER2-positive breast cancer, a particularly aggressive form of the disease driven by excess levels of a growth-promoting protein.
In the post-surgery trial, Enhertu cut the risk of the cancer returning or death by 53% compared with an existing treatment, with more than nine in ten patients alive and disease-free after three years.
The approvals trigger $155 million in milestone payments from AstraZeneca to its Japanese partner Daiichi Sankyo.
Enhertu is already approved in more than 95 countries for advanced breast cancer and now covers both early and late-stage disease in the US.