The approval of the first fixed dose combination of a beta blocker and angiotensin II receptor blocker, BYVALSON, by the U.S. Food and Drug Administration (FDA) was announced by Allergan plc today.
"The majority of patients with hypertension require two or more medications to achieve their blood pressure goals," Past President of the American Society of Hypertension and University of Connecticut Professor of Medicine and Hypertension and Clinical Pharmacology Division Chief Dr. William B. White said. "Nebivolol and valsartan are used widely in the management of hypertension and are effective drugs. The new fixed-dose combination BYVALSON, that includes these two therapies, offers reduction of blood pressure through multiple mechanisms of action."
The FDA approved BYVALSON after a Phase III clinical trial. The approximately 4,100 participants were randomized and evaluated through the eight-week efficiency and safety study. After four weeks, the BYVALSON participants showed significant reductions in their blood pressure.
"Achieving blood pressure control is critical to reducing the risk of serious and life-threatening cardiovascular events," Allergan Chief R&D Officer David Nicholson said. "There remains a need for new therapies, as observed by the nearly half of patients in the U.S. who remain uncontrolled. We are pleased with the FDA approval of BYVALSON, which will provide physicians a new fixed dose combination therapy treatment option for patients affected by hypertension."