Maruho receives manufacturing and marketing approval for Anti-Herpes Virus Agent "Amenalief® Tab. 200mg" in Japan
Osaka (Japan), July 3, 2017 - Maruho Co., Ltd ("Maruho", Head Office: Osaka, Japan, President and CEO: Koichi Takagi) announces that today it has received manufacturing and marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), for anti-herpes virus agent "Amenalief® Tab. 200mg" (INN: amenamevir) (hereinafter referred to as "the product") for the treatment of herpes zoster (shingles) in Japan.
The product is an anti-herpes virus agent with a novel mechanism of action created by Astellas Pharma Inc. ("Astellas"; Head Office: Tokyo, President and CEO: Yoshihiko Hatanaka). The product has been observed to inhibit the proliferation of the varicella-zoster virus (hereinafter VZV) by inhibiting the activity of the helicase-primase complex, which is essential for viral DNA replication. In August 2012, Maruho and Astellas agreed on a license agreement for the development and commercialization of the product in Japan, and Maruho has been progressing its development.
Herpes zoster (shingles) is a disease caused by reactivation of the chickenpox VZV in latently-infected nerve ganglia. The main treatment for shingles is anti-herpes virus agents.
The product is proven to be effective against VZV when administered once a day after meals. Also, since most of the product is excreted in feces, it is not necessary to adjust the dosage and administration according to creatinine clearance, an indicator of kidney function. Maruho hopes the product will contribute to the expansion of treatment options and improvement in adherence for the treatment of shingles in Japan.
Product Profile: Amenalief® Tab. 200mg
INN | Amenamevir |
Formulation/Dose | Film coated tablets containing 200mg of amenamevir in 1 tablet |
Indication | Herpes Zoster |
Dosage and Administration |
General administration for adults is 400mg of amenamevir once a day administered orally after a meal. |
Approval Requirements |
A pharmaceutical risk management plan should be properly designed and implemented |