News | October 21, 2013

FDA Grants Orphan Drug Designation to Lipiodol

October 21, 2013 – Guerbet announced that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for Lipiodol (Ethiodized Oil) Injection for management of patients with known hepatocellular carcinoma (HCC).

Lipiodol is currently under FDA evaluation for safety and efficacy with a proposed indication "for selective hepatic intra-arterial use in computed tomography (CT) of the liver to visualize and localize lesions in adults with known HCC."

Hepatocellular carcinoma prevalence in the United States has been estimated to affect approximately 35,000 U.S. patients in 2013. Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and potentially a seven-year market exclusivity period.

"We are very pleased to have been granted an orphan drug designation for Lipiodol," commented Yves L'Epine, Chief Executive Officer of Guerbet. "Patients with known HCC may have Lipiodol approved as part of their disease management as an option. We are excited to further expand development of Lipiodol to include the drug's potential use for selective hepatic intraarterial injection in computed tomography of the liver to visualize and localize lesions in adults with known HCC."

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