Cangene’s HepaGam B Approved for New Indication

Cangene Corp. received approval from the FDA for HepaGam B for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen (HBsAg)-positive patients. HepaGam B is Cangene’s Hepatitis B Immune Globulin Intravenous, which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. Clinical data showed HepaGam B was highly effective at preventing hepatitis B recurrence and the dosing regimen used demonstrated anti-HBsAg levels that exceeded target therapeutic levels.

HepaGam B is distributed in the U.S. by Apotex Corp., which recently expanded its distribution by placing the drug within Novation, LLC’s product line, making HepaGam B directly available to Novation’s healthcare organizations in the U.S.

“This is a very important approval and addresses a significant medical need,” said Dr. John Langstaff, Cangene’s president and chief executive officer. “And with the recent agreement for distribution of this product with Novation, the timing could not be better,” he said.

HepaGam B was approved by the FDA last year for treatment following acute exposure to blood containing HBsAg, and was approved earlier this year by Health Canada for prevention of Hepatitis B recurrence following liver transplantation in adult patients.