China's CDE accepts GSK's regulatory filing for RSV vaccine
Drugmaker GSK Plc said on Tuesday that China's Center for Drug Evaluation has accepted its regulatory filing for Arexvy, its recombinant, adjuvanted respiratory syncytial virus vaccine, for the prevention of lower respiratory tract disease in adults aged 60 and over.
GSK noted that, if approved, it would become the first RSV vaccine available to this age group in China to help protect against the "potentially serious consequences" of RSV.
The FTSE 100-listed firm noted that the submission was supported by a broad data package, including positive Phase III results from a trial in adults aged 60 and above in China, in which all primary endpoints were met and the vaccine showed an acceptable safety profile.
GSK added that a regulatory decision was expected to be made in 2027.
Reporting by Iain Gilbert at Sharecast.com
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