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EMA accepts GSK RSV older adult vaccine for review
EMA accepts GSK RSV older adult vaccine for review.
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[{"type":"text","content":"\n \n \n Issued: 28 October 2022, London UK\n \n \n \n \n \n \n \n \n GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment\n \n \n \n \n \n \n ·\n Application based on positive pivotal phase III data showing\n vaccine efficacy against\n respiratory syncytial virus-lower respiratory tract disease\n in adults aged 60 years and above with a favourable safety profile\n \n \n ·\n This is the second major regulatory milestone for the vaccine candidate following acceptance of a submission in Japan\n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for its respiratory syncytial virus (RSV) older adult vaccine candidate. \n \n \n \n \n \n MAAs may be eligible for accelerated assessment if the EMA's Committee for Medicinal Products for Human Use decides the product is of major interest for public health and therapeutic innovation.\n A European regulatory decision is anticipated in Q3 2023. If approved, GSK's RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect older adults from RSV lower respiratory tract disease (LRTD).\n \n \n \n \n \n The MAA is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, which showed high overall vaccine efficacy against RSV LRTD in adults aged 60 years and above. The vaccine was well tolerated with a favourable safety profile. The most frequent observed solicited adverse events were injection site pain, fatigue, myalgia, and headache. Consistent high vaccine efficacy was observed against LRTD in severe disease, adults aged 70-79 years, adults with underlying comorbidities and across RSV A and B strains.\n \n \n \n \n \n This is the second major regulatory development for GSK's RSV older adult vaccine candidate following Japanese regulatory submission acceptance in October 2022.\n GSK's RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant.\n There are currently no RSV vaccines for older adu...