FDA Panel Backs Oral Ganciclovir

The US Food and Drug Administration's Antiviral Drugs Advisory Committee has recommended approval of Syntex' New Drug Application for oral ganciclovir, which is intended as an alternative to the intravenous formulation used in the maintenance treatment of cytomegalovirus retinitis in immunocompromised patients.

The oral form may be used after a patient has been stabilized by appropriate intravenous induction therapy, said Syntex, and should be used only in patients for whom the risk of a more rapid rate of disease progression with the oral formulation is balanced by the benefits associated with avoiding daily iv infusions. The company said that it hoped that the agency would have completed its review of oral ganciclovir by year-end.

Syntex has submitted applications to market oral ganciclovir to regulatory agencies in 14 countries, and the company is awaiting regulatory reviews. The oral version has not yet been launched onto any market. Intravenous ganciclovir was first launched onto the market in the USA in July 1989 as Cytovene, and is now available in 45 countries.