by Playfuls Staff |
7th April 2007
Cangene Corporation reports that the United States Food and
Drug Administration ("FDA") has approved HepaGam B for use to prevent
hepatitis B recurrence following liver transplantation in hepatitis B surface [more]
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.
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.
