SB Files US Famvir sNDA For Herpes
SmithKline Beecham has filed a supplemental New Drug Application for a genital herpes indication for its antiviral Famvir (famciclovir) in the USA. The company recently launched the product for this indication in the UK (Marketletter May 1). Famvir was approved by the Food and Drug Administration for its first indication, the treatment of shingles, in June 1994.
The dossier was submitted on the basis of two Canadian Phase III trials involving over 1,000 patients. Both found that famciclovir achieved significantly faster "time to event" rates than placebo, including positive effects in treating all symptoms of genital herpes, such as duration of viral shedding, time to complete lesion healing and time to resolution of symptoms. Famvir has advantages over the only other approved drug for this indication, aciclovir, in that it is taken less frequently.
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