Thursday, October 4, 2012

Kyowa Hakko Kirin seeks MHLW approval for Additional Indications for Intramuscular Administration and Dosage of Leunase® Injection 5000 KU and Leunase® Injection 10000 KU

Leunase is indicated for patients with acute leukemia and malignant lymphoma. Currently  Leunase is indicated only intravenous injection. It has been found the chance of facing a hypersensitivity reaction is higher with intravenous injection as compared to intramuscular injection. Once hypersensitivity reactions including anaphylaxis are occured, subsequently administration would be difficult.


The Japanese Society of Pediatric Hematology/Oncology submitted a letter to the MHLW requesting the earliest possible approval regarding the administration and dosage of intramuscular injections of L-asparaginase (Leunase). Furthermore, at the Second Committee of the “New Drugs of the Pharmaceutical Affairs and Food Sanitation Council” held in September 2012, the committee concluded that an application based on the evidence in the public domain would be acceptable, in accordance with the assessment of the “Review Committee on Unapproved Drugs and Indication with High Medical Needs”

Following this conclusion, Kyowa Hakko Kirin filed an application of Leunase for additional indication based on evidence in the public domain.

About Application based on the evidence in the public domain
Clinical trials may be partially or completely omitted in the drug (additional efficacy, impact) approval application process for drugs that are commonly known to be effective in widely accepted medical and pharmaceutical realms.
About Review Committee on Unapproved Drugs and Indication with High Medical Needs
The Committee was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in the United States and Europe but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "Application based on evidence in the public domain" and investigating the need for studies that should be additionally conducted.