The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration says no to Actavis’ new application for a combination drug aimed to treat hypertension, according to the drug maker’s issued statement on Sept. 9.
Six members of the CRDAC voted against the recommendation of the said drug, a fixed-dose combination of valsartan and nebivolol.
"Although we are disappointed in the Committee's recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension," says David Nicholson, senior vice president of Global Brands Research and Development at Actavis.
The recommendation of the committee, however, isn’t binding on the FDA, because the latter still makes final decision on the approval.
Nicholson says that they remain confident in the efficacy and safety of the drug and still look forward to working with the agency as it completes the review, which the drug maker expects at the fourth quarter of this year.
Data presented to the CRDAC included phase III efficacy and safety data that came from nearly 5,000 patients involved in the clinical development program.
The Lancet published a significant study on the drug’s efficacy that indicates how the combined drug met the primary and key secondary endpoints, showing statistically important reductions from baseline systolic and diastolic blood pressure in eight weeks for hypertensive patients, as opposed to using nebivolol and valsartan separately.
The FDA approved both nebivolol and valsartan previously. Nebivolol, for one, is for treating hypertension and is effective in reducing blood pressure, either taken alone or combined with other antihypertensive agents. Meanwhile, valsartan is an efficient antihypertensive agent.
The Centers for Disease Control and Prevention called hypertension as "silent killer" for two reasons. One is because it shows no warning symptoms or signs and second is its relation with serious cardiovascular risks such as myocardial infarction and stroke.
The National Institute for Health Statistics says an estimate of 30 percent of adults in the U.S. has hypertension.
Based in Dublin, Ireland, Actavis is "focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world." It is described as a leader in the industry when it comes to research and development of drug products. It operates commercially in over 60 countries and in over 30 facilities distribution and manufacturing worldwide.
