SmithKline Beecham Gets Second Indication For Famvir In The USA

SmithKline Beecham's antiviral Famvir (famciclovir) has been approved by the US Food and Drug Administration for the treatment of recurrent episodes of genital herpes in immunocompetent adults, its second indication. The drug was cleared for marketing in the UK for this indication earlier this year and is currently approved in nearly 40 countries, including the USA, for the treatment of acute shingles (herpes zoster infection).

Famvir has also shown potential in reducing the duration of post-herpetic neuralgia, a serious complication of shingles, and is being studied for a number of other herpes infections. Further to this, the drug is also being evaluated in the treatment of hepatitis (Marketletter December 4). In Phase II trials for chronic hepatitis B infection, Famvir has demonstrated significant antiviral effect in interferon-unresponsive and refractory patients.

Unlike the current therapy for recurrent episodes of genital herpes (aciclovir), which needs to be taken five times daily, Famvir's dosage in this indication is 125mg twice daily. The product should be launched for this indication within the next few months.