Roche: Valcyte receives US approval for treatment of AIDS-related CMV retinitis
Oral drug with IV potency
Roche announced today that the U.S. food and Drug Administration (FDA) has approved Valcyte (valganciclovir) for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients. Valcyte is the oral pro-drug of Roche’s existing anti-CMV treatment, Cytovene (outside the US: Cymevene; ganciclovir) which is currently the most widely prescribed anti-CMV medication worldwide.
In a clinical study, Valcyte tablets were found to have comparable efficacy for induction therapy when compared to Cytovene-IV. The application for Valcyte received a priority review from the FDA, a designation reserved for treatments deemed to represent potentially major advances in healthcare.
“Since Cytovene was introduced in 1989, it has become the mainstay of anti-CMV treatment in patients with HIV/AIDS,” said Nick Coppard, Valcyte Project Leader, Roche. “We expect that Valcyte will replace and build upon Cytovene in the marketplace, because it offers comparable efficacy in a much more convenient dosing regimen for induction therapy.”
“CMV retinitis, which can lead to blindness, affects between 10 and 25 percent of people with the late stages of AIDS,” said Terje Anderson, executive director, National Association for People with AIDS, US. “It’s devastating to these patients to lose their eyesight at the same time they are fighting to survive. During the past few years, advances in treatments for HIV/AIDS have decreased the prevalence of opportunistic infections like CMV; however, there is still a need for convenient treatment regimens versusdrugs currently available for CMV retinitis,” Anderson added.
Studies in the prevention of CMV disease in solid organ transplantation recipients are underway and it is anticipated that applications for marketing authorisations for this indication will be filed in the second quarter, 2002.
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