PRINCETON, N.J.--(BUSINESS WIRE)--GE Healthcare announced today that the U.S. Food and Drug Administration (FDA) has designated for priority review the New Drug Application (NDA) for AdreView. AdreView is a molecular imaging agent for the detection of neuroendocrine tumors in pediatric and adult patients. The FDA also encouraged GE to establish an expanded access program for the agent. An expanded access program is designed to grant physicians limited access to a novel agent prior to FDA approval.
“We are extremely pleased that we have received the priority review for AdreView,” said Arnold Jacobson M.D., Ph.D., GE’s Clinical Project Leader for the AdreView program. “We believe this review designation reflects the appreciation of the potential importance of this agent for the diagnosis and management of these rare tumors. The expanded access program will provide immediate benefit to patients with these diseases, particularly children with neuroblastoma.”
GE Healthcare began development of AdreView in 2004, and the agent was granted orphan-drug designation by FDA in December of 2006.
GE’s NDA for AdreView was submitted March 20, and accepted by the FDA May 20th. A priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act, the FDA’s goal is to review and act on 90 percent of NDAs designated as priority review within six months of receipt.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE:GE - News). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
Contact:
GE Healthcare Ryan Fitzgerald 414-530-2735 ryan.fitzgerald@ge.com
Source: GE Healthcare
