Medical Device Network

Bracco abandons development of three barium-based imaging agents

The company discontinued three of its non-FDA-approved barium products citing a “significant decline” in barium-based product usage.

Bracco Diagnostics, a US subsidiary of Italian diagnostic imaging company Bracco Imaging, has discontinued the development of three of its barium products.

The company was light on details on the discontinued products, stating that the barium products were not approved by the US Food and Drug Administration (FDA). Bracco cited a “significant decline” in the use of these products as the reason for discontinuation.

Bracco was quick to add that it does not anticipate additional product discontinuations. Furthermore, the company is planning to file for US regulatory approval for its barium-based abdominal imaging agent later this year.

Barium imaging agents are commonly used to conduct contrast abdominal X-rays. These are used to diagnose a variety of upper and lower gastrointestinal disorders, including tumours, ulcers, and other inflammatory conditions.

The market for diagnostic imaging agents is expected to grow from being worth approximately $37.3bn in 2024 to over $47.5bn in 2030, as per GlobalData analysis. The sector for contrast agents, including barium-based products, is expected to grow from being worth $3.7bn to $4.3bn in the same period.

Bracco plans to launch three products in the next two years. CitraClear is a favoured beverage designed to increase the palatability of imaging agents and a launch is planned for the third quarter of 2024. In the following quarter, Bracco plans to launch a ‘Mini’ packaging version of its FDA-approved contrast agent, Varibar (barium sulphate). Next year, Bracco plans to launch a new flavour of a barium imaging agent for a CT [computed tomography] scan.

Multiple companies have developed imaging agents for different indications. In December 2023, Telix Pharmaceutical submitted a biologics licence application (BLA) to the FDA for its investigational positron emission tomography (PET) imaging agent, Zircaix (TLX250-CDx). The agent is designed to visualise clear cell renal cell carcinoma (ccRCC) by binding to carbonic anhydrase 9 (CAIX), which is over-expressed in these cancer cells.

In October 2023, FluoGuide’s optical imaging agent, FG001, received an orphan drug designation from the FDA. FG001 is a fluorophore that targets urokinase-type plasminogen activator receptor (uPAR), a cell surface protein usually found in metastatic cells. The agent is administered into a patient’s vein before surgery and ‘lights up’ the cancer cells during surgery. The highlighted section can then be resected without involving any healthy tissue.