Takeda Announces New Drug Application Approval in Japan for a Haemophilus influenzae type b conjugate vaccine, "VAXEM Hib"
Osaka, Japan, January 22, 2016 - Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application ("NDA") for a conjugate vaccine to prevent infections caused by Haemophilus influenzae type b (Hib) in children aged from 2 months to under 5 years of age. The vaccine was licensed from Novartis (Switzerland)* in May 2009 (Novartis' product name: VAXEM Hib). The vaccine is supplied as a suspension for injection that does not require reconstitution.
The application approval is based on positive Phase 3 clinical results of a multicenter, randomized, double-blind, parallel-group, comparative study in 416 Japanese children, which evaluated the safety and immunogenicity of this vaccine compared to a Hib vaccine licensed in Japan.
Hib frequently inhabits the nasopharynx (nose and throat) of individuals and can spread to other parts of the body, causing life threatening illness such as meningitis, pneumonia, or sepsis, particularly in young children. Hib meningitis can be fatal or result in long term disability, but can be prevented through immunization.
"The approval of this NDA will provide parents in Japan with an important option to help protect their children against illnesses caused by Hib," said Hitoshi Oinuma, Head of Takeda's Japan Vaccine Business Unit. "Takeda will continue to focus efforts on advancing public health in Japan and across the globe through the development of high quality vaccines that prevent disease and save lives."
* In April 2014 GlaxoSmithKline plc (GSK) announced a transaction with Novartis which closed in March 2015. As result of this transaction, GSK acquired Novartis' non-influenza global vaccines business including VAXEM Hib®.
Note: Haemophilus influenzae type b is a bacterium which is a main cause of pediatric meningitis, and it is completely different from the virus which causes "flu".
Approved Indication and dosage/administration
Indication Prevention of the bacterial infection, Haemophilus influenzae type b (Hib).
Primary series: Normally three 0.5mL doses, subcutaneously injected with an interval of at least three weeks between doses.
Booster: Normally, approximately one year after completion of the primary series, a single 0.5mL dose is subcutaneously injected.
Takeda's Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health. For more than 60 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases for which vaccines are needed, such as dengue and norovirus. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address the world's most pressing public health needs.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.