AstraZeneca gains approvals in Japan for Soliris and Lynparza

24 August 2023
astrazeneca_japan_large

UK pharma major AstraZeneca (LSE: AZN) today announced extended indication approvals of two major products in Japan.

First, the company’s Soliris (eculizumab) has been approved in Japan for expanded use to include the treatment of generalized myasthenia gravis (gMG) in pediatric patients who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). Soliris is the first and only targeted therapy approved for the treatment of children and adolescents with gMG in Japan, according to AstraZeneca.

The approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) was based on results from the Phase III trial of Soliris in pediatric patients with refractory gMG. Soliris was first approved in Japan in 2017 for the treatment of certain adults with gMG and is also approved for certain adults with gMG in the USA, China and the European Union (EU).

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology