Philadelphia, PA, July 29, 1997 -- SmithKline Beecham announced today that it has filed a supplemental new drug application with the U.S. Food and Drug Administration for the use of Famvir (famciclovir) in the treatment of herpes simplex virus (HSV) infections and acute herpes zoster (shingles) infections in immunocompromised patients. Herpesvirus infections are common in immunocompromised patients and can lead to increased morbidity.
In a double-blind, acyclovir controlled multicenter study, 148 immunocompromised patients (bone marrow transplant recipients and cancer patients) with herpes zoster were randomized to receive either Famvir 500mg three times daily or acyclovir 800 mg five times daily for ten days. The median time to complete healing of all lesions was comparable for patients treated with either Famvir or acyclovir. In addition, there were no significant differences between both treatment groups in times to loss of lesion associated symptoms or new lesion formation.
Famvir is indicated for the treatment of recurrent genital herpes and
acute herpes zoster in immunocompetent individuals. SmithKline Beecham
has filed a new drug application with the FDA for the use of penciclovir
IV in the treatment of mucocutaneous herpes simplex and herpes zoster
infections in immunocompromised individuals. Other studies are ongoing to
evaluate the use of Famvir in the treatment of herpes virus infections in
immunocompetent and immunocompromised individuals. In addition, studies
are ongoing in the treatment of chronic hepatitis B virus infection.