The Food and Drug Administration has approved a first-of-its-kind hypertension treatment that could become AstraZeneca’s next blockbuster product.
A once-daily tablet, Baxfendy is now cleared, in combination with other antihypertensive drugs, to lower blood pressure for adults whose condition isn’t adequately controlled. The FDA based its decision on a late-stage trial that had results published in the New England Journal of Medicine last summer.
The trial enrolled patients whose blood pressure remained hard to control blood despite the use of multiple therapies. Results showed that two different doses of Baxfendy were each significantly better than a placebo at reducing “seated blood pressure” — the standard measurement clinicans use to diagnose hypertension. The drug was also generally well tolerated, with most adverse events classified as mild. Of those, the most common were muscle spasms, dizziness, too-low blood pressure and abnormal levels of sodium and potassium in the blood.
Baxfendy doesn’t work like existing medications. It instead inhibits an enzyme that synthesizes “aldosterone,” a hormone which causes blood pressure to rise by telling the body to excrete potassium while retaining water and salt. AstraZeneca saw enough promise in this approach to acquire Baxfendy’s developer, CinCor Pharma.
CinCor had licensed the drug from Roche back in 2019, then went public three years later, raising nearly $200 million in the process. The AstraZeneca buyout came in 2023, carrying $1.3 billion in upfront payments and a 121% premium.
In a statement from AstraZeneca, Bryan Williams, a primary investigator in that key trial, said doctors “have been waiting for an innovative medication like Baxfendy for hypertension for many years.”
“Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension,” added Williams, who also serves as chair of medicine at University College London.
According to statistics cited by AstraZeenca, 1.4 billion people worldwide have hypertension. In the U.S., tens of millions of patients still grapple with elevated blood pressure even after taking two or more antihypertensive medications.
Executives have pegged Baxfendy as at least a $5-billion-per-year product. They argue that figure could grow larger, to roughly $10 billion, should the drug succeed in more clinical studies and in other indications like chronic kidney disease.
Baxfendy “is definitely a big product, and we’re all excited to see it launch in many countries very soon,” AstraZeneca CEO Pascal Soriot said in late April, during the company’s most recent earnings report.
In that report, AstraZeneca recorded a 7% increase in overall overhead costs, which was partly driven by prelaunch investments related to Baxfendy. The company expects the drug to be available in pharmacies no later than June 9.
The approval is somewhat of a double-edged sword for Mineralys Therapeutics, a Pennsylvania-based biotechnology company advancing its own medication that works like Baxfendy. The biotech’s shares were down 3% by late Monday morning.
Dennis Ding, an analyst at Jefferies who covers Mineralys, wrote in a note to clients that both drugs look similar on safety and effectiveness, so market success will likely boil down to commercial execution. There, AstraZeneca holds several advantages, including a large sales force with experience selling cardiovascular therapies.
Still, Ding believes the Baxfendy approval “should lift another gating factor” and “may be incrementally constructive” for any partnering discussions Mineralys might pursue, since it provides “visibility” into the labeling, pricing and payer access factors for these types of drugs.
