nebivolol and valsartan

nebivolol and valsartan

NDA Submitted for Nebivolol and Valsartan Combination

Forest Laboratories Submits NDA for Nebivolol and Valsartan Combination in Hypertension

NEW YORK--Thursday, February 27, 2014 8:00 am EST -(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX) announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for a fixed dose combination (FDC) of nebivolol and valsartan for the treatment of hypertension.

The application for the treatment of hypertension includes 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 5, 10, and 20 mg with valsartan 80, 160, and 320 mg versus 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.

“Despite the available options for the treatment of hypertension, many patients remain uncontrolled. Combining the well-established hypertension drugs, nebivolol and valsartan, could provide physicians and patients with an additional convenient option,” said Marco Taglietti, MD, Chief Medical Officer and EVP, Drug Development and Research at Forest Laboratories, Inc.

The single pivotal nebivolol/valsartan FDC trial was designed to meet the required regulatory “Combination Rule,” comparing the fixed dose combination against the highest approved doses of each component drug.

About Hypertension

Hypertension has been described as a “neglected disease” because of the lack of attention given to it and the serious cardiovascular (CV) consequences of having high Blood Pressure (BP), such as strokes and Myocardial Infarction (MI). The prevalence of hypertension is on the rise. According to the National Institute of Health Statistics, 28.6% of adults in the United States (~88 million) have hypertension. Inadequate treatment of hypertension is a significant public health problem. Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce CV morbidity and mortality, and it can be concluded that it is BP reduction that is largely responsible for those benefits. Elevated systolic or diastolic pressure causes increased CV risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so even modest reductions of severe hypertension can provide substantial benefit. Two-thirds of patients will require more than one drug to achieve BP goals.

About Nebivolol/Valsartan FDC

Nebivolol/valsartan (5/80mg, 5/160mg, 10/160mg, 10/320mg, and 20/320mg) is an investigational fixed dose combination. Nebivolol/valsartan FDC combines two FDA-approved, once-daily, blood pressure lowering agents with different mechanisms of action. It is being evaluated as a potential treatment for hypertension in patients who need combination therapy.

In the Phase III pivotal 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 versus corresponding monotherapies were also statistically significant at 8 weeks. The FDC also met the key secondary endpoint of change from baseline in systolic blood pressure (SBP) at 8 weeks.

Treatment with nebivolol/valsartan FDC was well-tolerated in the study. Across all FDC doses the most common adverse events (incidence ≥ 2% and greater than placebo) were fatigue (0.9% to 2.3% vs. 1.1% in placebo) and dizziness (1.6% to 2.3% vs. 0.4% in placebo).

Nebivolol (marketed in the U.S. as BYSTOLIC®) is cardioselective up to and including the 10mg dose and in extensive metabolizers. While nebivolol’s mechanism of action has not been definitively established, possible factors include vasodilation and decreased peripheral vascular resistance (PVR). Other possible factors include reduced heart rate and myocardial contractility, suppression of renin, and reduced sympathetic activity. Nebivolol is indicated for the treatment of hypertension and is effective at lowering blood pressure when taken alone or in combination with other antihypertensive agents.

Valsartan is an angiotensin II receptor blocker (ARB) that blocks the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby preventing its vasoconstrictor and aldosterone-secreting effects. Valsartan has been well studied in many different patient populations and is an effective antihypertensive agent.

About Forest Laboratories

Forest Laboratories, Inc. (NYSE:FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. The Company markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in the following therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, anti-infective, and cystic fibrosis. Our strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships, and targeted mergers and acquisitions allows us to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. The Company is headquartered in New York, NY. To learn more, visit Forest’s Web Site at www.frx.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.

Source: Forest Laboratories, Inc.

Posted: February 2014

nebivolol and valsartan FDA Approval History

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