GSK PLC (LSE:GSK, NYSE:GSK) has said it is on course to have its new RSV vaccine fast-tracked in Europe after the EMA validated its marketing application based on impressive results from a recent phase III trial.
That study showed 83% efficacy against respiratory syncytial virus-lower respiratory tract disease in adults aged 60 years and above with a favourable safety profile (read more).
Currently, there are no RSV vaccines approved for older adults anywhere in the world.
A submission in Japan for the vaccine was also recently accepted, while the European regulatory decision is anticipated in the third quarter of 2023.
RSV is a common contagious virus affecting the lungs and breathing passages with the dangers increasing as people get older.
Each year, RSV causes over 420,000 hospitalisations and 29,000 deaths in adults aged 60 years and above in industrialised countries.
Separately, GSK said the EMA had also validated subsidiary, ViiV Healthcare’s marketing application for its cabotegravir long-acting HIV preventative.
In a statement, Kimberly Smith, head of research & development at ViiV, said: "With approximately 100,000 people in Europe newly diagnosed with HIV each year, this submission is an important step forward in offering expanded options for HIV prevention.
“Long-acting prevention options, if used appropriately and at scale, could have the potential to transform the shape of the HIV epidemic."
Cabotegravir long-acting is an injectable treatment administered six times a year.