Forest Labs announced that it has submitted a New Drug Application (NDA) to the FDA for a once-daily, fixed dose combination (FDC) of nebivolol, a cardioselective beta-blocker and valsartan, an angiotensin II receptor blocker (ARB) for the treatment of hypertension.
The submission included results from an 8-week randomized, double-blind, placebo-controlled pivotal clinical trial in 4,161 hypertensive patients which studied different fixed combinations of nebivolol 5mg, 10mg, and 20mg with valsartan 80mg, 160mg, and 320mg vs. placebo and compared to the individual drugs alone. It also includes the results from a 52-week, open-label study which assessed long-term safety/tolerability of the free tablet combination of nebivolol and valsartan in 807 patients.
In the Phase 3 trial, the combination of nebivolol and valsartan demonstrated statistically significant reductions in diastolic blood pressure (DBP) vs. the highest approved doses of both nebivolol alone (40mg) and valsartan alone (320mg) at 8 weeks, which was the primary endpoint. The DBP reductions for the other FDC doses vs. corresponding monotherapies were also statistically significant at 8 weeks.
The FDA has already approved Bystolic (nebivolol) and valsartan as single agents for the treatment of hypertension.
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