GSK seeks Japanese approval for respiratory disease vaccine

Japan's medicines regulator has agreed to review GSK's vaccine candidate for respiratory disease, the UK drugs group said on Friday.

The blue chip confirmed that its application for its respiratory syncytial virus (RSV) older adult vaccine candidate has been accepted for review by the Japanese Ministry of Health, Labour and Welfare.

It is seeking approval for the vaccine's use in adults aged 60 and over to prevent lower respiratory tract diseases caused by RSV following "positive data" from an interim analysis of a phase III trial. GSK said the trial had shown "high overall vaccine efficacy…with a favourable safety profile".

The application is the latest for the vaccine candidate, with authorities in the US and European Union expected to make their decisions before the year end.

There is currently no vaccine for RSV, a common contagious virus affecting the lungs and breathing passages.

GSK was created earlier this year when GlaxoSmithKline spun out its consumer healthcare division as Haleon. The remaining business, rebranded GSK, is solely focused on vaccines and prescription medicines.

As at 0845 BST, shares in GSK were largely flat at 1,371.2p.