Source: DGNews  |  Posted 3 years ago

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.

SOURCE: Talecris