Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced that today it had filed an application for approval of the additional indication of febrile neutropenia for ZOSYN® 2.25 and ZOSYN® 4.5, an antibacterial combination product with β-lactamase inhibitor for intravenous injection (generic name: tazobactam·piperacillin) in Japan.
Japan's Ministry of Health, Labour and Welfare's (MHLW) Study Group on Unapproved and Off-label Drugs of High Medical Need*1 received requests from a related medical society to develop this drug for the indication of febrile neutropenia, and the Study Group assessed that there was a strong medical need for this indication. As a result, in December 2010, the MHLW requested that Taiho develop ZOSYN® for this indication, and a clinical study was subsequently begun.
Taiho remains committed to making further contributions to patients and medical practitioners engaged in the treatment of infectious diseases.
ZOSYN® is an injectable antibacterial combination product consisting of the β-lactamase inhibitor tazobactam that Taiho discovered and the semisynthetic antibiotic piperacillin that Toyama Chemical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masuji Sugata) discovered in a ratio of 1:8 in potency for intravenous administration. Taiho holds the marketing authorization for ZOSYN® in Japan, and Taisho Toyama Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Akira Ohira) is marketing the product. In July 2008, ZOSYN® was approved in Japan for the treatment of septicemia, pneumonia, pyelonephritis, and complicated cystitis in adults and children. In September 2012, it received approval for the indications of peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis. ZOSYN® is approved in 102 countries*2. ZOSYN® is recommended in the guidelines issued by the medical societies in the countries including the US and Europe for treatment of various infectious diseases, and is well recognized as a standard therapeutic agent for bacterial infections around the world.
About febrile neutropenia
Patients suffering from solid tumor or hematopoietic diseases such as acute leukemia are treated with a variety of chemotherapies and radiation therapies. Febrile neutropenia is a febrile disease that occurs when neutropenia (lower than normal neutrophils counts) accompanies bone marrow suppression caused by these treatments. It advances suddenly and becomes life threatening but is known to improve upon administration of broad-spectrum antibiotics.
*1: The Study Group was established for the purpose of assisting pharmaceutical companies in their efforts to develop drugs or indications that are not approved in Japan but are approved for use in the US and Europe. The Study Group evaluates medical needs for the drugs and indications, and assesses the suitability of the public knowledge-based application and the additional trials required for the approval application.
*2: As of October 2012