Health Canada Approves Liquid Immune Globulin IV for Chronic Inflammatory Demyelinating Polyneuropathy

[CIDP]

Health Canada Approves Liquid Immune Globulin IV for Chronic
Inflammatory Demyelinating Polyneuropathy
NEW YORK -- October 14, 2008 -- Health Canada has granted approval for
liquid immune globulin intravenous (IGIV [Gamunex]) as a treatment for
chronic inflammatory demyelinating polyneuropathy (CIDP).

The approval is based on a large-scale clinical trial which validated
the long-term safety and efficacy of the liquid IGIV therapy as a
first-line and maintenance treatment for CIDP.

"The ICE study was a pivotal trial in showing that [IGIV] was superior
to placebo in reducing functional disability and improving grip
strength in CIDP patients," said study coauthor Vera Bril, MD,
University Health Network and Mount Sinai Hospital, Toronto, Ontario.

"This was the largest trial ever conducted in CIDP and was important
in showing that patients treated with [IGIV] could maintain long-term
benefit versus placebo and that patients who continued to receive
[IGIV] had a significantly longer time to relapse than did placebo
trial subjects."

IGIV products have been reported to be associated with renal
dysfunction, acute renal failure, osmotic nephrosis and death.
Hemolytic anemia, haemolysis, and haemolytic reaction have been
reported rarely in association with use of IGIV. There have also been
reports of noncardiogenic pulmonary edema, very rarely aseptic
meningitis, and thrombotic events in patients administered with IGIV.

The most common side effects noted during clinical trials included
headache, vomiting, fever, nausea, rash, and back pain.