VIENNA - Italian contrast firm Bracco Imaging is reviving plans to launch its SonoVue contrast agent in the U.S. The Milan firm plans to sponsor a multicenter clinical trial this year to collect data for a regulatory submission to the U.S. Food and Drug Administration (FDA).
Bracco began selling SonoVue in Europe in 2001 and has shipped more than 1 million vials of the agent, according to Dr. Maurizio Denaro, group vice president of R&D. The company had planned to introduce the product in the U.S., but its schedule was derailed in 2007 when the FDA announced that it would require black box warnings for the two ultrasound contrast agents currently on the market, following reports of 11 deaths in heart patients after contrast administration.
Bracco was in the final stages of a regulatory submission for SonoVue in 2007, but withdrew the application following the issuance of the black box warning. Currently, the only ultrasound contrast agents on the U.S. market are Definity from Lantheus Medical Imaging of North Billerica, MA, and Optison from GE Healthcare of Chalfont St. Giles, U.K.
In recent months, however, several new clinical studies have demonstrated that severe reactions to ultrasound contrast are rare. Bracco's own data indicate that reactions -- the vast majority of which are mild -- occur in one of 12,000 cases of SonoVue administration, Denaro said. Indeed, the FDA relaxed the black box language required for Optison and Definity in July 2008 to state that contrast should be contraindicated in only the most unstable heart patients.
Bracco has determined that now would be a good time to restart the regulatory process for SonoVue, and the company is lining up 15 to 20 sites in the U.S. and Canada to conduct clinical trials with the product for both cardiac and noncardiac applications, Denaro said. The sites should begin acquiring patients in the next three months, and Bracco hopes to have SonoVue on the U.S. market by 2011.
In Europe, Bracco is planning several clinical trials to support expanded applications for SonoVue. These include use in myocardial perfusion, guiding prostate biopsy procedures, and monitoring cancer treatment, according to Denaro.
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