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Pharmaceuticals and Medical Device Agency approval summary: Amenamevir for the treatment of herpes zoster
Author(s) -
Shoji Naoko,
Tanese Keiji,
Sasaki Ayano,
Horiuchi Taishi,
Utsuno Yuji,
Fukuda Koichi,
Hoshino Yukiko,
Noda Shinichi,
Minami Hirofumi,
Asakura Wataru
Publication year - 2020
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/1346-8138.15393
Subject(s) - medicine , famciclovir , christian ministry , agency (philosophy) , marketing authorization , nucleoside analogue , authorization , summary of product characteristics , pharmacology , family medicine , drug , bioinformatics , virology , chemistry , philosophy , virus , theology , computer security , epistemology , nucleoside , computer science , stereochemistry , biology
In July 2017, Japan’s Ministry of Health, Labor and Welfare issued a marketing authorization valid throughout Japan for N ‐(2,6‐dimethylphenyl)‐ N ‐(2‐{[4‐(1,2,4‐oxadiazol‐3‐yl)phenyl]amino}‐2‐oxoethyl)‐1,1‐dioxothiane‐4‐carboxamide (amenamevir) for the first time worldwide. The decision was based on the favorable opinion of the Pharmaceuticals and Medical Device Agency (PMDA) recommending a marketing authorization of amenamevir for treatment of herpes zoster (HZ). Amenamevir has a different action mechanism from previously approved synthetic nucleoside compounds for the treatment of HZ including acyclovir, valacyclovir and famciclovir. The usual adult dose is 400 mg amenamevir p.o. once daily for 7 days. The benefit is its ability to cure HZ as well as preventing postherpetic neuralgia. The most common side‐effects are increase of urine N ‐acetyl‐β‐D‐glucosaminidase and α1‐microglobulin levels. However, based on the detailed evaluation of the submitted clinical studies, there seems to be no serious safety concerns about amenamevir regarding the kidney of both renally normal and impaired patients. The objective of this article is to summarize the scientific review of the application. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the PMDA website ( www.pmda.go.jp/PmdaSearch/iyakuSearch/ ).