If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Committee Backs Valganciclovir HCl To FDA For AIDS-Related Cytomegalovirus Retinitis GAITHERSBURG, MD -- February 28, 2001 -- Roche announced that the U.S. Food and Drug Administration (FDA) Anti-Viral Drugs Advisory Committee (AVAC) unanimously recommended the use of valganciclovir HCl for maintenance therapy and issued a 12-1 recommendation for induction therapy for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. AVAC's vote to recommend approval was made after the company presented data comparing treatment of CMV retinitis with valganciclovir, which is taken orally, to treatment with Cytovene®-IV (ganciclovir). Valganciclovir is the pro-drug of Cytovene (ganciclovir), also made by Roche, which is currently the most widely prescribed anti-CMV medication worldwide. As a pro-drug of ganciclovir, valganciclovir is rapidly converted to ganciclovir in the body. "We are very pleased with the committee's recommendation," said James A. Thommes, M.D., medical director, virology, Roche Laboratories. "Over the past decade, the treatment of people with HIV/AIDS has changed dramatically, which has made it more difficult to recruit and conduct studies for CMV and other opportunistic infections in people with HIV. As a result, we've worked particularly closely with the FDA on the development program that responded to the changing patient needs and allowed the continued development of this important compound." Roche filed a new drug application (NDA) with FDA in September 2000 for approval to market valganciclovir for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. Advisory committee recommendations are not binding on the FDA. Roche scientists presented the AVAC with data from a randomized, controlled study in patients with AIDS and newly diagnosed CMV retinitis which compared the efficacy of valganciclovir and Cytovene IV in CMV induction therapy. Patients received either valganciclovir (900 mg BID for 21 days, then 900 mg QD for seven days) or Cytovene-IV (5 mg/kg BID for 21 days, then 5 mg/kg QD for 7 days) after which all patients in the study received open-label valganciclovir maintenance therapy. Analysis of the primary CMV progression endpoint revealed that after 4 weeks of therapy, the proportion of patients with progression as measured by retinal photography was the same in both treatment groups. Of the evaluable patients in the efficacy analysis in the Cytovene - IV group, this was seven of 70; in the valganciclovir group, it was 7 of 71. Safety data was presented for 370 patients who received valganciclovir for an average of 320 days. In general, valganciclovir's adverse event profile was similar to ganciclovir and included low blood cell counts (granulocytopenia, anemia, thrombocytopenia), diarrhea, nausea, vomiting, fever and fatigue. In animal studies, ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis. Cytomegalovirus (CMV), a member of the herpes family of viruses, infects approximately 50 to 75 percent of the U.S. adult population. In individuals with healthy immune systems, CMV exists in the body in a dormant state. Among individuals with compromised immune systems, such as those with HIV/AIDS or patients taking post-transplant immunosuppressants, the virus can become active and cause disease. In people with HIV/AIDS, the most common manifestation of CMV is CMV retinitis, a sight-threatening form of this disease. Although retinitis may develop without symptoms, when symptoms do occur they include visual problems, such as blind spots, distorted vision and noticeable blurring. Because these problems can happen in diseases other than CMV retinitis, a physician must make the diagnosis of CMV retinitis.
|
