The FDA also approved Famvir (famciclovir) as a single-dose treatment for recurrent herpes labialis (cold sores) in immunocompetent patients.
When an outbreak of recurrent genital herpes (RGH) is triggered in the body, there is a narrow window of opportunity for treatment since the virus is replicating most actively in the first hours of an outbreak. Data shows that when patients were treated with the oral antiviral Famvir during this critical period of time, it shortened the duration of outbreaks and improved the time to resolution of symptoms.
Similarly, the cold sore virus is most active during the first hours of an outbreak. Data shows that when a single 1,500mg dose of Famvir therapy is initiated within one hour of the first sign of symptoms (tingling, itching or burning) of a cold sore, Famvir significantly reduced the time to healing by a median of almost two days, as well as the time to resolution of pain and tenderness by a median of one day.
“Famvir is the first and only antiviral approved to treat recurrent genital herpes in a single day,” said Dr Gregory Geba, vice president and therapeutic area head of respiratory, dermatology and infectious diseases at Novartis. “The new data demonstrates that Famvir can minimize a recurrent genital herpes outbreak, and stop symptoms such as pain and burning, in a median of less than a day. More importantly, Famvir can also stop an outbreak from occurring altogether in many patients.”
Including these two new indications, Famvir is now approved for the treatment or suppression of RGH in immunocompetent patients, the treatment of recurrent herpes labialis (cold sores) in immunocompetent patients, the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients, and the treatment of acute herpes zoster (shingles).