Kyowa Hakko files for additional indications for Leunase
Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) says that it has filed an application based on evidence in the public domain to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking approval for additional dosage and administration for intramuscular administration and dosage of Leunase (L-asparaginase) Injection 5000 KU and Leunase Injection 10000 KU.
Leunase is indicated for patients with acute leukemia and malignant lymphoma, and its efficacy is based on the depletion of L-asparagine, which is required by tumor cell growth. However, once hypersensitivity reactions including anaphylaxis occurred, subsequently administration would be difficult. In Japan, Leunase is indicated only as intravenous injection, however it is reported that the incidence of hypersensitivity is lower for intramuscular injection than for intravenous injection.
Application based on evidence in the public domain deemed acceptable
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 accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- 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
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze