FDA approves Allergan's fixed-dose combo for hyertension
- The FDA has approved Byvalson, which combines the beta blocker (BB), nebivolol (5 mg) and the angiotensin II receptor blocker (ARB) (80 mg), valsartan, in a fixed-dose combination (FDC) formulation.
- In phase 3 clinical trials, Byvalson produced a statistically significant reduction in blood pressure, compared with either nebivolol or valsartan alone.
- Allergan plans to launch Byvalson the second half of this year.
Byvalson is the first FDA-approved drug that combines a BB and an ARB for the treatment of hypertension. While it's true that hypertension is associated with an increased risk of serious cardiovascular (CVD) events such as stroke, heart failure and heart attack, there are no data to support the link between use of Byvalson and reduced risk of CVD events. Nonetheless, the correlation between reducing hypertension and improving long-term outcomes is generally recognized, regardless of how this treatment goal is achieved.
In a statement from Allergan, Dr. William B. White, immediate past president of the American Society of Hypertension, emphasized the role of combination therapy in treating hypertension.
He said, "The majority of patients with hypertension require two or more medications to achieve their blood pressure goals. Nebivolol and valsartan are used widely in the management of hypertension and are effective drugs. The new fixed-dose combination Byvalson, that includes these 2 therapies, offers reduction of blood pressure through multiple mechanisms of action," he said.