SMITHKLINE BEECHAM FILES WITH THE FDA FOR THE USE OF FAMVIR IN IMMUNOCOMPROMISED PATIENTS

Studies Show Famvir Safe and Effective for Immunocompromised Patients

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.

Studies Show Famvir is An Effective and Convenient Treatment

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.