The recommendation by the European member states to approve Valcyte for this new indication means that patients can soon be prescribed an effective CMV preventative therapy with a much simpler regimen than the current standard therapy. Valcyte delivers the same safety and efficacy as the current gold standard therapy, ganciclovir, but with the added advantage of a simpler, oral, once-daily, patient-friendly dosing regimen - two tablets taken once daily compared to twelve capsules taken in three doses daily.
Welcoming the news of Valcyte's approval, Dr Mark Pescovitz, Professor of Surgery and Microbiology/Immunology, and Director of Transplant Surgery at Indiana University, USA, says: "We know the potential dangers of CMV disease. With Valcyte's approval, I feel confident we can now provide patient-friendly, convenient oral preventative therapy with efficacy as good as the current gold standard, Cymevene."
"CMV disease continues to pose a real and life-long threat to the recovery and health of many solid organ transplantation patients," continues Dr Pescovitz. "The clinical impact of this threat can include hepatitis, pneumonia and chronic injury of the grafted organ."
The European approval is based on data from a 6 month non-inferiority study of 372-high risk patients that shows that a 900mg once-daily dose of Valcyte is as consistent as a 1000mg three times per day dose of ganciclovir in preventing CMV disease, with a similar safety profile.
"Valcyte's approval reinforces Roche's ongoing commitment to develop innovative therapies in post-transplantation care," says Hari Kumar, Global Leader Valcyte, Roche. "The simpler dosing regimen of Valcyte is a further improvement for patients in whom compliance can be an issue."
About CMV
CMV is a member of the herpes family of viruses. In individuals with healthy immune systems, after initial infection, CMV can exist in the body in a dormant state. However, among individuals with compromised immune systems, such as patients taking post-transplant immunosuppressants or those with HIV/AIDS, the virus can become active causing disease and organ damage. CMV disease occurs in up to 40% of organ transplant recipients and is responsible for a substantial number of deaths and graft failures in these patients. CMV disease may affect the transplanted organ by causing direct as well as insidious damage, and/or by developing infection by opportunistic pathogens.
About Valcyte
Valcyte, a prodrug of Roche's existing anti-CMV treatment, Cymevene, was developed in response to the need for more convenient and patient-friendly administration of ganciclovir. Cymevene is the number one treatment of choice for CMV disease worldwide.
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REFERENCES
1 Rubin RH, Wolfson JH, Cosimi AB, et al. Infection in the renal transplant patient. Am J Med 1981; 70:405-411
2 Patel R, Paya CV. Infections in solid-organ transplant recipients. Clin Microbiol Rev 1997; 10:86-124
NOTES TO EDITOR
About Roche
Headquarters in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 62,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.