Health Canada has issued a Notice of Compliance with conditions which confers marketing approval to the drug in Canada, while requiring the company to continue with a confirmatory clinical study. The approved indication is for the prevention of hepatitis B recurrence following liver transplantation in adult patients who have low levels or no hepatitis B virus replication.
HepaGam B is the only intravenous product licensed in Canada for this indication. A Notice of Compliance with conditions is granted to provide patients who are suffering from serious, life-threatening or severely debilitating illnesses or conditions, accelerated access to promising new therapies.
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.