Specifically, this approval is for post-exposure prophylaxis use of HepaGam B, ie for treatment of acute exposure to blood containing hepatitis B surface antigen (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 infection. Health Canada has granted a full notice of compliance with no conditions for this use of the drug, the company said.
HepaGam B is a purified antibody or hyperimmune that is specific for hepatitis B virus. HepaGam B is also approved by the FDA for this indication and for use in liver transplant recipients; HepaGam B is reportedly the only hepatitis B immune globulin product approved for both these indications in North America.
John Langstaff, president and CEO of Cangene, said: “This approval is another good addition to our product line-up. It represents the culmination of a great deal of work by our clinical and regulatory teams. Data supporting this indication was collected from a very large study that was conducted largely in India; it was one of the largest clinical trial programs ever conducted there.”