The Food and Drug Administration has approved an expanded indication for CytoGam.
The immune globulin previously was indicated only in some kidney transplants, but it now can be used for prophylaxis against cytomegalovirus (CMV) disease associated with lung, liver, pancreas, heart, and kidney transplants.
"CMV is the most common cause of infection occurring after any solid organ transplant. This expanded indication will enable us to market CytoGam for use in the approximately 20,000 kidney, lung, liver, pancreas, and heart transplants performed annually in the U.S., rather than being restricted to the roughly 2,000 kidney transplants from CMV-seropositive donors to CMV-seronegative recipients," said David P. Wright, a vice president at MedImmune, which markets CytoGam and other products for use in transplantation medicine.
In related news, the FDA has approved Rebetron combination therapy, which includes Schering-Plough's Rebetol (ribavirin) capsules and Intron (interferon alfa-2b) injection, for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon therapy. In June, Rebetron combination therapy was approved for treating chronic hepatitis C in patients with compensated liver disease who relapsed following alpha interferon therapy.
The FDA also has approved Glaxo Wellcome's Epivir-HBV (lamivudine), the first oral antiviral medication for the treatment of adults with chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation. Epivir-HBV, which acts directly to interfere with viral replication, was evaluated in four controlled studies conducted for a year in 967 patients with chronic HBV. Glaxo Wellcome said in a press release that the safety and effectiveness of treatment with Epivir-HBV beyond one year have not been established.
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