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February 21, 2013

Approval for Additional Indications for Intramuscular Administration and Dosage of Leunase® Injection

Tokyo, Japan, February 21, 2013-Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that Japan's Ministry of Health, Labour and Welfare ("MHLW") approved additional dosage and administration for intramuscular administration and dosage of Leunase® Injection 5000 KU and Leunase® Injection 10000 KU (brand name / generic name: L-asparaginase, "Leunase®").

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 are occurred, subsequently administration would be difficult. In Japan, Leunase® is indicated only intravenous injection, however it is reported that the incidence of hypersensitivity is lower for intramuscular injection than for intravenous injection.

Under these circumstances, 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 in October 2012.

Kyowa Hakko Kirin believes that the additional indication of Leunase® for administration and dosage will significantly contribute to the treatment of acute leukemia and malignant lymphoma.

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.


Kyowa Hakko Kirin
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