In September 2022, Bracco Diagnostics Inc. announced US Food and Drug Administration (FDA) marketing approval for its new VUEWAY™ Gadopiclenol Injection. VUEWAY was approved under the FDA’s priority review process for products that represent significant improvements in safety or effectiveness.
“We are very excited to bring VUEWAY Gadopiclenol Injection to the market, and we’re excited about the promise it may hold for our customers and their patients,” said Cosimo De Pinto, senior vice president of sales and marketing at Bracco Diagnostics.
There was significant buzz about VUEWAY at the Radiological Society of North America (RSNA) 2022 Scientific Assembly and Annual Meeting in Chicago. “In over 25 years at RSNA, I've never seen the level of enthusiasm and anticipation for a product as we're seeing for VUEWAY,” said De Pinto.
Noelle Heber, senior director, contrast media marketing, of Bracco Diagnostics said VUEWAY is part of Bracco’s dedication to the radiology industry. “Everything that we do at Bracco is dedicated to partnering with radiologists and helping them achieve their goals,” she said.
VUEWAY is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). The approved dose is 0.05 mmol/kg.
De Pinto believes Gadopiclenol has the potential to make a significant impact in contrast imaging. “VUEWAY is different,” he said. “We're excited for our customers, but more importantly, we're also excited about what it may represent to patients care.”
Gadopiclenol injection is the result of a strategic global collaboration agreement between Bracco and Guerbet in research, development and manufacturing. Heber said the collaboration will expand access to VUEWAY. “The goal of the partnership is to get it into the hands of more radiologists and eventually into more patients,” she said.
Guerbet and Bracco will commercialize their Gadopiclenol injection products independently under different brand names in the US. A Centralized Application for Marketing Authorization for Gadopiclenol Injection was submitted to the European Medicines Agency (EMA) earlier this year.
Bracco will offer extensive support and education to help clinicians become familiar with VUEWAY. “Bracco is known for our customer support, and that’s what you’ll get when you choose Bracco for this product,” said Heber. “Customers can expect more clinical support and education about the nuts and bolts of the product, as well as how to use it.”
Bracco has also launched an all-new website dedicated to information about VUEWAY™, and customers can contact their Bracco representative for more information. “One of our strengths at Bracco is our people, and our representatives are prepared to support our customers when they ask about VUEWAY™,” said Heber.
For Bracco, the launch of VUEWAY means staying at the forefront of what's important to radiologists and their patients. “We're committed to advancing patient care, and we’re committed to advancing diagnostic imaging in any way that we can,” said De Pinto.
Bracco expects to eventually introduce VUEWAY to countries around the globe. “We have a responsibility to take the knowledge about utility of this product that we gain from the US and share it with the rest of the world,” he said.
For more information about Vueway™ and to see the full prescribing information click here!Back To Top
The Promise of VUEWAY™ Gadopiclenol Injection . Appl Radiol.
McKenna Bryant is a freelance healthcare writer based in Nashotah, WI.