GSK wins EU nod for RSV vaccine marketing authorization application

GSK (LSE/NYSE:GSK) has won validation of the marketing authorization application from the European Medicines Agency (EMA) for its respiratory syncytial virus (RSV) vaccine candidate. GSK is pursuing authorization to use the vaccine annually in older adults.

European regulators will likely announce a final regulatory decision in the third quarter of 2023.

The vaccine candidate would be the first vaccine to protect adults 60 and older from the respiratory syncytial virus.

GSK submitted positive data from an interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) Phase 3 study. The trial indicated that the vaccine efficacy had high overall efficacy against RSV LRTD in adults 60 and older.

In the study, the RSVPreF3 vaccine candidate demonstrated statistically significant and clinically meaningful efficacy in the target demographic.

The study involved about 25,000 participants from 17 countries.

The experimental va…

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