FDA Advisory Committee Says No To Actavis' Investigational Hypertension Treatment
By Lori Clapper
Actavis has announced that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) did not approve the New Drug Application (NDA) for its fixed-dose combination treatment targeted for hypertension. The committee vote was six to four recommending against approval, according to the company press release.
The regimen is an investigational fixed-dose combination, combining two FDA approved, once daily, blood pressure lowering agents, nebivolol and valsartan. The information that was presented to the advisory committee included phase III efficacy and safety data from the almost 5,000-patient nebivolol/valsartan clinical study.
The regulators were basing their decision on whether or not Actavis’ combination of nebivolol and valsartan would be a more effective treatment than just prescribing the highest dose monotherapy of one of the medicines, Bloomberg reported. In addition, a report from the FDA’s Division of Cardio-Renal Drug Products argued that the path to controlling blood pressure would be longer if taking the combination therapy.
“Approving a drug with a very small effect like this will lead to choosing this agent over other combinations or other individual agents that work better,” James DeLemos, a panelist and cardiology service chief at Parkland Memorial Hospital in Dallas, told Bloomberg. “So I think that we don’t need 47 combinations of blood pressure medicines.”
The committee recommendation may not directly impact the FDA’s final approval or rejection of the drug, and Actavis expects the agency to make its final decision by the fourth quarter of 2014.
"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," David Nicholson, SVP, Global Brands Research and Development, Actavis, said. The company says that it remains confident in the treatment’s potential and looks forward to hearing the FDA’s decision by the end of the year.
Hypertension is considered a significant public health issue, impacting approximately 30 percent of adults in U.S. More than half of all patients do not achieve their target goals in treatment, while two-thirds of hypertension patients need to take more than one drug in order to get their condition under control.