FDA Approves Hypertension Drug Byvalson

Feb 02, 2007; Irvine, CA, USA; Allergan, Inc., with headquarters in Irvine, California, is a global specialty pharmaceutical company that develops and commercializes innovative products for the eye care, neuromodulator, skin care and other specialty markets. In addition to its discovery-to-development research programs, Allergan has global marketing and sales capabilities in over 100 countries that deliver value to our customers, satisfy unmet medical needs and improve people's lives. Driven by technology and innovation, Allergan addresses the needs of consumers across the world with over 5,000 employees worldwide, 4 world-class Research and Development facilities and 3 state-of-the-art manufacturing plants (Credit Image: © Camilla Zenz/ZUMAPRESS.com)

Steve’s breakdown: Byvalson is the first fixed-dose beta blocker/ARB combo in the U.S. so we think there may be decent ad dollars behind the drug. Allergen is the owner of the brand and my sources do not list an AOR. Here’s their number 862-261-7000

PARSIPPANY, NJ: Byvalson (nebivolol/valsartan, Allergan) 5 mg/80 mg tablets have won FDA approval for the treatment of patients with hypertension to lower blood pressure. Byvalson is the first fixed-dose combination (FDC) of a beta blocker (BB) and an angiotensin II receptor blocker (ARB) available in the United States.

The FDA’s decision was based on positive data from a phase 3, double-blind, placebo-controlled, dose-escalating efficacy and safety study, published in The Lancet, which enrolled approximately 4,100 patients with stage-1 or -2 hypertension. In this pivotal trial, treatment with the FDC of nebivolol and valsartan for four weeks demonstrated statistically significant reductions from baseline in diastolic and systolic blood pressure compared with either nebivolol alone or valsartan alone. The overall rates of adverse events were similar across the treatment groups and placebo during the four-week treatment period.

Nebivolol (Bystolic, Allergan) is a BB that is preferentially beta-1 selective up to and including the 10-mg dose and in extensive metabolizers. While the mechanism of action of nebivolol has not been definitively established, possible factors include vasodilation, decreased peripheral vascular resistance, reduced heart rate, myocardial contractility, renin suppression, and reduced sympathetic activity.

Valsartan is an ARB that blocks the binding of angiotensin II to the angiotensin II, type 1 (AT1) receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby blocking its vasoconstrictor and aldosterone-secreting effects.

Byvalson may be used alone or in combination with other antihypertensive agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a variety of pharmacological classes, including the BB class to which nebivolol principally belongs and the ARB class to which valsartan principally belongs. No controlled trials have demonstrated risk reduction with Byvalson.

Allergan expects the product to be available in the second half of 2016.

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