FDA approves Cangene hepatitis B product

Patients who undergo hepatitis B-related liver transplantation require long-term post-transplant therapy with hepatitis B immune globulin. Clinical trial data showed HepaGam B was highly effective at preventing hepatitis B recurrence and the dosing regimen used consistently yielded anti-HBsAg levels that exceeded target therapeutic levels.

HepaGam B was approved last year by the FDA for treatment following acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute hepatitis B virus infection.

The prodcut was also approved earlier this year by Health Canada for prevention of hepatitis B recurrence following liver transplantation in adult patients. HepaGam B is a hyperimmune product that can be used in situations where a vaccine is not applicable.

Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids and it can recur after liver transplantation in patients who are HBsAg-positive at the time of transplant. Recurrence results from the infection of the liver graft with hepatitis B virus that had remained in circulation.