Takeda submits new drug application in Japan for TAK-816

Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it has submitted a New Drug Application (“NDA”) to the Japanese Ministry of Health, Labour and Welfare for a vaccine against infections caused by Haemophilus influenzae type b (Hib) (Development code: TAK-816). This vaccine, if approved, will provide an additional option for pediatricians to prevent invasive Hib disease in Japanese children.

Hib bacteria frequently inhabit the nasopharynx (nose and throat) of individuals without causing disease. However, on occasion these bacteria can become invasive and cause serious life threatening illness such as meningitis. Hib meningitis can be fatal or result in long term disability, outcomes that are preventable through immunization. TAK-816 is a Hib vaccine licensed from Novartis (head office: Basel, Switzerland) in May 2009 (Novartis’ product name: Vaxem Hib®). It is provided in a liquid form and does not require reconstitution before use.

The NDA includes study results of a Phase 3 multicenter, randomized, double-blind, parallel-group, comparative study in Japanese children. A total of 416 subjects were randomized to receive either TAK-816 or another Hib vaccine presently used in Japan. Results from the study, which evaluated the immunogenicity and safety of this vaccine have provided very positive results and it is expected that the new vaccine will have a major impact on the disease burden in Japanese children.

“This is Takeda’s second NDA filing since the launch of the Vaccine Business Division in January, 2012, and demonstrates our commitment to the health of children in Japan,” said Dr. Rajeev Venkayya, Head of the Vaccine Business Division at Takeda. “We are also committed to improving the lives of populations around the world, and are working to develop safe and effective vaccines to address important unmet needs in global public health, including dengue, norovirus and hand, foot and mouth disease.”

Invasive disease due to Haemophilus influenzae type b

Haemophilus influenzae type b (Hib) can cause serious invasive disease, especially in young children. The incidence of severe illness is highest in the first year of life and occurs much less commonly after the age five. The most common associated illnesses include pneumonia, meningitis (inflammation of the protective lining of the brain), epiglottitis (inflammation of the entrance to the airways), septic arthritis, osteomyelitis, cellulitis and pericarditis. Importantly, complications of Hib meningitis may include epilepsy, auditory disturbance, development disorders and other neurological conditions.

Individuals can carry Hib bacteria in their nose and throat without showing signs of the disease. These bacteria can be spread from person to person through coughing, sneezing or close contact with a carrier or an infected person. Hib vaccination, in addition to helping to protect the vaccinated individual against invasive disease, also reduces the amount of bacteria that are carried in the nose and throat and therefore reduces the risk of transmission of these bacteria to others.

About TAK-816

TAK-816 is a Hib vaccine licensed from Novartis in May 2009 (Novartis’ product name: Vaxem Hib®). It contains 10µg of Poly-Ribosyl-Ribitol-Phosphate as the antigenic component conjugated to 25µg of cross reactive material 197 (CRM197). CRM197 is a non-toxic variant of Diphtheria toxin isolated from cultures of Corynebacterium diphtheriae C7 (beta 197) commonly used in vaccines for infants to make them work in these very young individuals. TAK-816 also contains aluminium phosphate as an adjuvant to enhance the immune response to the vaccine.