Regado receives Fast Track designation from FDA for REG1

Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the development of actively controllable therapeutics, today announced that the United States Food and Drug Administration (FDA) has designated REG1 for anticoagulant therapy to be used in patients with coronary artery disease during percutaneous coronary interventions (PCI) as a Fast Track development program. The FDA's Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions that fill an unmet medical need, with the overall goal of getting new drugs to patients earlier. 

"We are pleased that the FDA has designated REG1 as a Fast Track development program in our lead indication of PCI," said David J. Mazzo, Ph.D., Chief Executive Officer of Regado Biosciences. "We continue to believe that REG1 has the potential to become a new standard of care for anticoagulation in interventional cardiology. We intend to continue our Phase 3 REGULATE-PCI study with the goal of bringing this important new therapy to patients as quickly as possible."

Robert M. Califf, M.D., Professor of Medicine at the Duke University Medical Center in Durham, N.C., Chairman of Regado Biosciences' Medical Advisory Board and recognized thought leader, said, "If REGULATE-PCI meets its primary endpoints, REG1 will offer a clinically meaningful advantage versus currently available therapies by enabling interventional cardiologists to actively control anticoagulation during PCI. Fast Track designation is an important step in the process of demonstrating REG1's promise to improve outcomes for patients."

REG1 is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen, for use during revascularization procedures such as PCI. These procedures put patients at risk for therapy-related ischemic and bleeding complications. REG1 is designed to improve patient outcomes, enable physicians to have direct therapeutic control and provide efficiencies leading to significant pharmacoeconomic benefits. REG1 is currently being evaluated in the Phase 3 REGULATE-PCI trial.