Application for approval of Famvir® anti-herpes agent for additional indication

February 1, 2012
Maruho Co., Ltd.
Asahi Kasei Pharma Corp.

On January 31, 2012, Asahi Kasei Pharma Corporation filed an application for approval of the antiviral agent Famvir® (generic name: famciclovir), which was developed in Japan jointly with Maruho Co., Ltd., for the additional indication of herpes simplex.

Asahi Kasei Pharma obtained marketing approval for Famvir® in Japan, where it has been distributed under license by Maruho for the indication of herpes zoster (shingles) since July 2008. If famciclovir receives approval for the new indication, this will benefit patients by providing a new option for treatment of herpes simplex.

Novartis Pharma AG granted Asahi Kasei Pharma Corporation the right to distribute Famvir® in Japan pursuant to a Restated Distribution Agreement effective January 29, 2008. Famvir® is a registered trademark of Novartis Pharma AG.

About famciclovir

Famciclovir is the oral prodrug of the antiviral agent penciclovir, which is a nucleoside analogue DNA polymerase inhibitor that suppresses the proliferation of herpes viruses. Once famciclovir is taken by a patient, it is quickly metabolized to penciclovir, which is specifically phosphorylated within cells infected by herpes virus, forming penciclovir triphosphate. This suppresses herpes viral replication by termination of the viral DNA chain.

About herpes simplex

Herpes simplex is a disease caused by the herpes simplex virus initially infecting the skin and mucosa, or reactivation of the virus in latently-infected nerve ganglia. Once infection occurs, symptomatic recurences may occur. Classifications of the disease include herpes labialis, herpes facialis, herpes genitalis, and Kaposi varicelliform eruption, depending on the affected area and clinical condition. Prodromal symptoms include itching and discomfort, followed by the outbreak of lesions. Cutaneous lesions begin with erythema and papules. These are followed by vesicles, pustules, erosion, and ulcers, which lead to the development of crusts. The skin eventually heals as the crusts fall off. Although initial infection is often asymptomatic, the disease may cause severe systemic symptoms such as pyrexia, lymphadenopathy, and pain. Currently available treatments include aciclovir and valaciclovir hydrochloride.


Adobe Readeris required to view these PDF files.

page top