Valcyte receives Dutch regulatory approval for treatment of AIDS-related CMV retinitis

Roche Pharmaceuticals have announced that valganciclovir (Valcyte™) for the treatment of AIDS-related cytomegalovirus (CMV) retinitis has received its first European regulatory approval from the Dutch Medicines Evaluation Board. The Dutch regulatory approval will be used to initiate a mutual recognition procedure with pan-European approval of Valcyte expected by mid-2002.

Valcyte is a prodrug of Roche’s existing anti-CMV treatment, Cymevene® (ganciclovir), developed in response to the need for more convenient and patient-friendly administration of ganciclovir. The introduction of Valcyte means that patients with acute CMV retinitis will only have to take two Valcyte tablets twice-daily rather than receive two IV infusions a day. For patients receiving maintenance treatment aimed at preventing relapse or progression of CMV retinitis, two Valcyte tablets once-daily will replace a daily Cymevene IV infusion or up to 12 Cymevene capsules daily on a three times daily basis. Cymevene is currently the most widely prescribed anti-CMV medication worldwide.

The approval was supported by clinical studies that show Valcyte tablets have comparable efficacy for induction therapy when compared to intravenous Cymevene. In the U.S. Valcyte received approval following priority review from the Federal Drug Administration, a designation reserved for treatments deemed to represent potentially major advances in healthcare.

Comment

Valganciclovir has been available in the UK through special licence sales similar to a named-patient programme.

Doctors should contact Deborah Vincent on 01707 367857 at Roche laboratories directly to register patients for this programme and for further information.