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Press release from PR Newswire

GSK Receives FDA Approval for MenHibrix®

Thursday, June 14, 2012

GSK Receives FDA Approval for MenHibrix®21:45 EDT Thursday, June 14, 2012-- First combination vaccine to help prevent meningococcal serogroups C and Y and Hib diseasePHILADELPHIA, June 14, 2012 /PRNewswire/ -- GlaxoSmithKline plc (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved the vaccine MenHibrix® [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine]. MenHibrix is a vaccine indicated to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. MenHibrix is approved for use in children aged six weeks through 18 months. The vaccination schedule for MenHibrix is a four-dose series given at two, four, six, and 12 through 15 months of age. The first dose can be given as early as six weeks of age and the last as late as 18 months of age. MenHibrix was developed to align with the Centers for Disease Control and Prevention's recommended infant immunization schedule for Hib vaccination and to allow for vaccination against meningococcal groups C & Y without adding additional shots. GSK will provide additional details on when MenHibrix will be available in the near future."All of us at GSK Vaccines look at today's approval as a good day for infants, toddlers and healthcare providers," said Leonard Friedland, M.D., Vice President, Head, Clinical and Medical Affairs, North America Vaccine Development, GSK Vaccines. "MenHibrix gives healthcare providers the option of combining Hib immunization with meningococcal C and Y immunization without increasing the number of shots for infants and toddlers." The basis for FDA approval of MenHibrix included data GSK submitted from clinical trials conducted in the United States, Mexico, Australia, Belgium and Germany over seven years in which 7,521 infants and toddlers received at least one dose of MenHibrix. Of these participants, 3,349 were located in the United States.  Adverse events in clinical trials included pain and redness at the injection site, irritability, drowsiness and loss of appetite. About Meningococcal DiseaseMeningococcal disease is a rare but serious bacterial infection caused by the bacterium N. meningitidis.  The highest incidence of meningococcal disease, across all serogroups, occurs in infants and toddlers <2 years of age(1). Meningococcal disease is unpredictable, can be difficult to diagnose and can rapidly worsen within 24 to 48 hours after the onset of symptoms. While serogroup distribution may vary from year to year, serogroups B, C, and Y cause most cases of meningococcal disease in the United States.  The most common vaccine-preventable serogroups are C and Y.  No vaccine is currently available in the United States to protect against serogroup B.About Hib DiseaseHib disease is caused by the bacterium Haemophilus influenzae type b, which most commonly presents as meningitis.  Hib was the leading cause of bacterial meningitis in the United States among children younger than 5 years of age before the introduction of effective Hib vaccines.  The disease has been virtually eliminated through routine infant vaccination.  In the United States, most cases of Hib disease occur in under-immunized children and infants who are too young to have completed the primary immunization series.Important Safety Information for MenHibrixA severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b-, meningococcal-, or tetanus toxoid-containing vaccine or any component of MENHIBRIX is a contraindication  If Guillain-Barre (GBS) syndrome occurred within 6 weeks of  receipt of a prior vaccine containing tetanus toxoid, the decision to give and tetanus toxoid-containing vaccine, including MENHIBRIX, should be based on careful consideration of the potential benefits and possible risks Syncope (fainting) can occur in association with administration of injectable vaccines, including MENHIBRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including MENHIBRIX, to infants born prematurely should be based on consideration of the individual infant's medical status, and the potential benefits and possible risks of vaccination. Rates of local injection site pain, redness, and swelling ranged from 15% to 46% depending on reaction and specific dose in schedule. Commonly reported systemic events included irritability (62% to 71%), drowsiness (49% to 63%), loss of appetite (30% to 34%), and fever (11% to 26%) (specific rate depended on the event and dose in the schedule). Vaccination with MENHIBRIX may not result in protection in all vaccine recipients GlaxoSmithKline VaccinesGlaxoSmithKline Vaccines, a division of GlaxoSmithKline group, is the world's leading vaccine company and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved and 20 more in development - both in the prophylactic and therapeutic fields. Headquartered in Belgium, GSK Vaccines has 14 manufacturing sites strategically positioned around the globe. In 2011, GSK Vaccines distributed 1.1 billion doses to 173 countries in both the developed and the developing world.Through its accomplished and dedicated workforce, GSK Vaccines applies its expertise to the discovery of innovative vaccines that contribute to the health and well-being of people of all generations around the world.GlaxoSmithKline ? one of the world's leading research-based pharmaceutical and healthcare companies ? is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com GlaxoSmithKline Enquiries:UK Media enquiries:David Mawdsley+44 (0) 20 8047 5502(London)Stephen Rea+44 (0) 20 8047 5502(London)Sarah Spencer+44 (0) 20 8047 5502(London)David Daley+44 (0) 20 8047 5502(London)US Media enquiries:Rob Perry+1 215 751 7583(Philadelphia)Karen Collins +1 919 483 2527(North Carolina)Analyst/Investor enquiries:Sally Ferguson+44 (0) 20 8047 5543(London)Tom Curry+ 1 215 751 5419(Philadelphia)Gary Davies+ 44 (0) 20 8047 5503(London)Jeff McLaughlin+ 1 215 751 7002(Philadelphia)Ziba Shamsi+ 44 (0) 20 8047 3289(London) Cautionary statement regarding forward-looking statementsUnder the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.  Reference 1.  Cohn AC, MacNeil JR, Harrison LH, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010;50(2):184-191. p 190, col 1, par 3, lines 2-4.http://dx.doi.org/10.1086/649209  Registered in England & Wales:No. 3888792Registered Office:980 Great West RoadBrentford, MiddlesexTW8 9GS SOURCE GlaxoSmithKline