FDA Approves Cangene's HepaGam B for Liver Transplant Recipients
Cangene Corporation today reports that the United States Food and Drug Administration has approved HepaGam B for use to prevent hepatitis B recurrence following liver transplantation in hepatitis B surface antigen ("HBsAg")-positive liver transplant patients.
HepaGam B is Cangene's Hepatitis B Immune Globulin Intravenous (Human), which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. 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 is distributed in the U.S. by Apotex Corp., which recently expanded its distribution by successfully placing the drug within Novation, LLC's product line-up, making HepaGam B directly available to Novation's nearly 2,500 member healthcare organizations in the United States.
"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 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, and was approved earlier this year by Health Canada for prevention of Hepatitis B recurrence following liver transplantation in adult patients.
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.
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Cangene manufactures HepaGam B in its Winnipeg facility using a process similar to that of WinRho(R) SDF, Vaccinia Immune Globulin and VariZIG, the Company's other hyperimmune products that have been approved in Canada and/or the United States.
A vaccine for hepatitis B is available, yet the virus continues to cause significant disease worldwide and pose a significant public health problem. Hyperimmune products can be used in situations where a vaccine is not applicable. Approximately 60,000 new infections are seen annually. There are an estimated 1.25 million chronically infected Americans, 20-30% of whom were infected as children. Severe liver disease is seen in 15-25% of chronically infected people.
HepaGam B is Hepatitis B Immune Globulin Intravenous (Human), a purified gamma globulin fraction of human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease ("CJD") agent. Individuals known to have severe, potentially life-threatening reactions to human globulin should not receive HepaGam B or any other immune globulin (Human). Individuals who are deficient in IgA may have the potential for developing IgA antibodies and have severe, potentially life-threatening allergic reactions. The maltose contained in HepaGam B can interfere with some types of blood glucose monitoring systems. Only testing systems that are glucose-specific should be used in patients receiving HepaGam B. This interference can result in falsely elevated glucose readings that can lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia.
The most common expected adverse drug reactions for immune globulins
like HepaGam B are chills, fever, headaches, vomiting, allergic
reactions, nausea, arthralgia and moderate low back pain.
For prevention of hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients, HepaGam B should be administered intravenously.
For post-exposure prophylaxis, HepaGam B must be administered only intramuscularly. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B, should be given only if the expected benefits outweigh the potential risks.