Pharmaceuticals and Medical Device Agency approval summary: Amenamevir for the treatment of herpes zoster

Naoko Shoji, Keiji Tanese, Ayano Sasaki, Taishi Horiuchi, Yuji Utsuno, Koichi Fukuda, Yukiko Hoshino, Shinichi Noda, Hirofumi Minami, Wataru Asakura

Research output: Contribution to journalReview articlepeer-review

2 Citations (Scopus)

Abstract

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/).

Original languageEnglish
Pages (from-to)683-688
Number of pages6
JournalJournal of Dermatology
Volume47
Issue number7
DOIs
Publication statusPublished - 2020 Jul 1
Externally publishedYes

Keywords

  • amenamevir
  • helicase–primase inhibitor
  • herpes zoster
  • pharmaceuticals and medical device agency
  • renal failure

ASJC Scopus subject areas

  • Dermatology

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