Cangene's Hepatitis B Therapeutic Approved in Canada for a Second Indication
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Cangene Corporation has reports that its HepaGam B® (Hepatitis B Immune Globulin (Human) Injection) has been approved by the Biologics and Genetic Therapies Directorate of Health Canada for treating acute exposure to hepatitis B virus. This is the second approved indication in Canada. HepaGam B® is a purified antibody or hyperimmune that is specific for hepatitis B virus.
Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids from an infected person or can be transmitted from an infected mother to a newborn during birth. HepaGam B® is also approved by the U.S. Food and Drug Administration (FDA) for this indication and for use in liver transplant recipients; HepaGam B® is the only hepatitis B immune globulin product approved for both these indications in North America.
"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," said Dr. John Langstaff, Cangene's president and CEO. "This approval also allows us to market the product to a broader customer base," he said.
Specifically, this approval is for post-exposure prophylaxis use of HepaGam B®, i.e. 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 (NOC) with no conditions for this use of the drug. A two-year-earlier Canadian approval (NOC/c) for use in liver transplant recipients, which made the drug available for those in need of the treatment, included the condition that the Company complete a confirmatory clinical study.
An NOC/c is granted to provide patients who are suffering from serious, life-threatening or severely debilitating illnesses or conditions, accelerated access to promising new therapies.
Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids from an infected person or can be transmitted from an infected mother to a newborn during birth. HepaGam B® is also approved by the U.S. Food and Drug Administration (FDA) for this indication and for use in liver transplant recipients; HepaGam B® is the only hepatitis B immune globulin product approved for both these indications in North America.
"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," said Dr. John Langstaff, Cangene's president and CEO. "This approval also allows us to market the product to a broader customer base," he said.
Specifically, this approval is for post-exposure prophylaxis use of HepaGam B®, i.e. 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 (NOC) with no conditions for this use of the drug. A two-year-earlier Canadian approval (NOC/c) for use in liver transplant recipients, which made the drug available for those in need of the treatment, included the condition that the Company complete a confirmatory clinical study.
An NOC/c is granted to provide patients who are suffering from serious, life-threatening or severely debilitating illnesses or conditions, accelerated access to promising new therapies.
