New hypertension drug gets FDA approval

June 7, 2016

The first and only fixed-dose combination of a beta blocker beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the US in the second half of the year. FDA approved nebivolol and valsartan (Byvalson, Allergan) 5 mg/80 mg tablets in early June.

The first and only fixed-dose combination of a beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the United States in the second half of the year.

FDA approved nebivolol and valsartan (Byvalson, Allergan) 5 mg/80 mg tablets in early June.

Related: Major diabetes drug cuts heart attack risk

"The majority of patients with hypertension require two or more medications to achieve their blood pressure goals," said William B. White, MD, professor of medicine and chief of the Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center at UConn Health and immediate past president of the American Society of Hypertension. "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."

FDA’s approval of Byvalson was based on a phase 3, double-blind, placebo-controlled, dose-escalating, 8-week efficacy and safety study, published in The Lancet.

Related: â€˜Beyond the pill’: Novartis eyes new pricing model for heart failure drug

In the study, treatment with the fixed-dose combination of nebivolol and valsartan for 4 weeks demonstrated statistically significant reductions from baseline in diastolic and systolic blood pressure versus either nebivolol alone or valsartan alone. The overall rate of adverse events was similar across treatment groups and placebo during the 4-week period.

While lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events—primarily strokes and myocardial infarctions—there are no controlled trials demonstrating risk reduction with Byvalson.

In hypertensive patients, greater than 20% increases in serum potassium were observed in 4.4% of valsartan-treated patients compared to 2.9% of placebo-treated patients. As a result, discontinuation of Byvalson may be required.

Byvalson is contraindicated in the following conditions: severe bradycardia, heart block greater than first degree, patients with cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), patients with severe hepatic impairment (Child-Pugh >B), and patients who are hypersensitive to any component of this product.

Also, physicians should not co-administer aliskiren with Byvalson in patients with diabetes.

Read more: FDA grants priority review to heart failure drug