FDA Approval Of Roche's Cytovene

Hoffman-La Roche has received clearance from the US Food and Drug Administration to market its oral Cytovene (ganciclovir) for the prevention of cytomegalovirus in solid organ transplant recipients.

Approval for the new indication was given based on the results of GAN 040, a 304-patient, double-blind, placebo-controlled trial. Patients were randomized to receive oral ganciclovir three times a day, at a dose of 1000mg, or matching placebo for 14 weeks following transplantation.

Over a period of six months, an 18.9% incidence of CMV disease was noted in the placebo group, compared with a 4.8% incidence in the ganciclovir-treated group. Of the treated group, only 0.7% of patients developed the severest form of the infection, invasive tissue disease, compared to 8.4% of the placebo recipients. Side effects of the therapy include infection, fever and headache.