Roche received confirmation that the Mutual Recognition Procedure has been completed for Valcyte (valganciclovir) for the prevention of cytomegalovirus (CMV) disease. CMV is a potentially fatal infection that frequently threatens the health of people who have received a solid organ transplantation.
The agreement 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. Valcyte's new regimen allows a 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 William M. Burns, Head of Roche's Pharma Division. "The simpler dosing regimen of Valcyte is a further improvement for patients in whom compliance can be an issue."
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 per cent 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.
Valcyte was first approved in the United States in 2001 for use in HIV patients, and European approval for this indication followed in 2002. Roche expects Valcyte to receive US approval for use in organ transplant patients later this year. Valcyte, a next generation drug 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.