First Hypertension Drug of Its Kind Obtains FDA Approval

June 7, 2016

The combination of nebivolol/valsartan (Byvalson) lowers blood pressure better than either drug by themselves.

The combination of nebivolol/valsartan (Byvalson/Allergan) lowers blood pressure better than either drug by itself.

Allergan, a pharmaceutical company based in New Jersey, announced on June 6 that the US Food and Drug Administration (FDA) approved the nebivolol/valsartan (5 mg/80mg) tablet. This is the first and only fixed-dose combination (FDC) of a beta blocker (BB) and angiotensin II receptor blocker (ARB) that will be available in the country. It’s indicated to lower blood pressure in the treatment of hypertension.

“The majority of patients with hypertension require two or more medications to achieve their blood pressure goals,” William B. White, MD, from the University of Connecticut Health Center, said in the company’s statement.

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A phase III study consisting of about 4,100 patients with stage 1 or 2 hypertension confirmed efficacy and safety during eight weeks of treatment. Statistically significant reductions in diastolic and systolic blood pressure were apparent after just four weeks. Patients had similar adverse event rates whether they received the drug or placebo, as published in The Lancet.

“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,” White continued.

The combination tablet is expected to hit the market in the second half of this year.

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