GlaxoSmithKline Files US Application For Approval Of Its MMR Vaccine

  • GlaxoSmithKline Plc GSK has submitted a marketing application to the FDA seeking approval for PRIORIX for use in active immunization against infection by measles, mumps, and rubella (MMR).
  • GSK MMR vaccine is available in Europe since 1997. The safety of PRIORIX was evaluated in six clinical studies. Total of 17,393 subjects received at least one dose of either PRIORIX or Measles, Mumps, and Rubella Virus Vaccine, Live (M-M-RII) from Merck & Co Inc MRK
  • The efficacy of PRIORIX was demonstrated based on comparative immunogenicity data with M-M-RII. 
  • The most commonly reported adverse reactions were pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever. 
  • If approved, PRIORIX would provide US healthcare providers with another MMR vaccine choice. 
  • GSK is also seeking approval for PRIORIX administration as a second dose to individuals who received another MMR vaccine.
  • Price Action: GSK shares are up 0.3% at $40.25 during the market session on the last check Monday.
  • Related content: Benzinga's Full FDA Calendar.

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