PRINCETON, N.J. - Guerbet, a pioneer in the field of contrast agents for medical imaging announced that Lipiodol® was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). HCC is the most common primary liver tumor and represents the third-leading cause of cancer-related death in the world, with prevalence in US estimated to affect in the range of 35,000 U.S. patients in 2013.
As previously announced in October 2013, Lipiodol has received an orphan-drug designation for management of patients with known HCC.
"Guerbet is pleased to have been granted approval for use of Lipiodol in patients with known HCC. This product has been supplied during the past three years under a temporary importation program. Guerbet's efforts to improve the availability of Lipiodol in the USA are in line with our company mission offering reliable and innovative solutions to improve the efficacy of Interventional Radiology procedures," commented Massimo Carrara, Guerbet US General Manager.
This approval was received shortly after FDA granted approval to a new site to manufacture Lipiodol, validated for US distribution only (Jubilant HollisterStier, Canada).
"The additional indication approved by FDA is a major milestone on the ambitious approach taken by the company to keep the product accessible for US patients to assist in the management of this devastating disease. We are pleased to receive FDA authorization which assures continuous accessibility to this drug to many HCC patients across America," said Corina Harper, Guerbet Director of North America Medical and Regulatory Affairs.
Guerbet plans to transition from the temporary importation program as soon as product from the newly approved manufacturing plant will be available in the US. For more information about the temporary importation program, please see the Dear Healthcare Professional Letter.
Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding.