FDA approves first-in-class hypertension drug from AstraZeneca
The U.S. Food and Drug Administration (FDA) has approved baxdrostat, sold by AstraZeneca under the brand name Baxfendy, for the treatment of hypertension in combination with other antihypertensive medications in adults.
Baxdrostat is a first-in-class aldosterone synthase inhibitor (ASI) designed to lower a patient's blood pressure by inhibiting the production of the hormone aldosterone. The FDA's approval was based on positive results from the BaxHTN Phase III trial, which linked baxdrostat with statistically significant and clinically meaningful seated systolic blood pressure reductions in 2-mg and 1-mg doses in patients. The company said the drug was generally well-tolerated in patients with uncontrolled, resistant hypertension.
“We 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," BaxHTN primary investigator Professor Bryan Williams, chair of medicine at University College London, explained in a statement.
He said the trial showed nearly double-digit placebo-adjusted systolic blood pressure reductions for baxdrostat. Epidemiological data also indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of patients experiencing a serious cardiovascular event.
“Hypertension remains a staggeringly widespread silent killer and a leading risk factor for stroke, heart attack, kidney damage and dementia. Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments. Innovative, new treatments could help millions protect their heart, kidney and brain health,” John M. Clymer, executive director of the National Forum for Heart Disease and Stroke Prevention, said in the same statement.
Today's FDA clearance will likely help pave the way for a second ASI drug from a competitor. Mineralys has developed the ASI lorundrostat, which is currently under FDA review. The drug's Phase 3 Launch-HTN trial showed clinically meaningful, durable reductions in systolic blood pressure in adults on two to five background antihypertensive medications.
“Today’s approval establishes aldosterone synthase inhibition as a therapeutic class for the millions of patients whose hypertension has not responded adequately to standard treatments, and the clinical evidence consistently reflects that. Hypertension disproportionately burdens older adults, women, Black Americans, and people with obesity - populations that have historically been underrepresented in clinical trials and undertreated in clinical practice," said Jon Congleton, CEO of Mineralys Therapeutics, in a separate statement.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]