GlaxoSmithKline Receives Complete Response from FDA for Candidate Meningococcal and Hib Combination Vaccine

Issued: London, UK

GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine, MenHibrix^® (Hib-MenCY). The proposed indication for this combination vaccine is immunization of infants and toddlers against meningococcal serogroups C & Y, and Haemophilus influenzae type b (Hib) diseases at two, four, six and 12-15 months of age. Meningococcal and Hib diseases are caused by potentially deadly bacteria that can lead to meningitis and other very serious complications.

A Complete Response letter is issued by FDA when the review of a file is completed and questions remain to be answered prior to approval. GSK will work to respond to the questions posed by FDA. The company remains committed to making this vaccine available in the United States.

The BLA submission included data from randomized, multicenter studies conducted in five countries with more than 9,000 infants. The vaccine demonstrated immunogenicity with a safety profile comparable to other US-licensed Hib vaccines in infants and toddlers when administered at two, four, six and 12-15 months of age. If approved, this combination vaccine would be administered in accordance with the existing CDC-recommended Hib vaccination schedule without increasing the number of shots given in the first two years of life.

Notes to Editors

About Meningococcal Disease

Meningococcal disease most commonly presents as meningitis, an infection that causes inflammation of the membranes covering the brain and spinal cord, as well as meningococcal sepsis, an infection of the blood. According to the CDC, approximately 1,000 to 3,000 cases of meningococcal disease are reported every year in the U.S. across all age groups; approximately 300 cases are reported annually in infants and toddlers under two years of age.Children under the age of two, adolescents and young adults are at high risk of getting the disease. However, infants and toddlers younger than two years of age have the highest rates of meningococcal disease. Neisseria meningitidis serogroups B, C and Y are the leading cause of meningococcal disease overall in the U.S. and the serogroup distribution varies from year to year. Serogroup B currently causes about 50% of disease in those under two years of age and is not currently preventable by vaccine. Serogroups C&Y currently cause approximately 40% of disease in children under two years of age.

Regardless of age, meningococcal disease is a severe and devastating disease among all age groups, with one in every ten cases leading to death in the U.S.As many as one in five patients who survive meningococcal disease suffer long-term consequences such as hearing loss, brain damage, amputations, and skin scarring, which often require lifelong medical attention and expenses.

About Haemophilus influenzae type b (Hib)

Hib disease is a serious, potentially life-threatening illness, with a number of complications. Invasive Hib disease is caused by bacteria called Haemophilus influenzae type b (Hib). The most common type of invasive Hib disease is meningitis.Hib disease usually occurs in children under five years of age, and immunization is the best preventive measure against the disease. In the U.S., invasive infections due to Hib occur primarily in under-immunized children and among infants too young to have completed the primary immunization series. Due to routine use of the Hib conjugate vaccine since the late 1980’s, the incidence of Hib disease in infants and young children in the U.S. has decreased by more than 99 percent.

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