GSK secures EMA review for single‑dose Bexsero booster.
Drugmaker GSK said on Monday that the European Medicines Agency had accepted its submission to update the label for its Bexsero asset, allowing for a single‑dose booster in people aged 10 and over who were previously vaccinated in childhood.
Source: Sharecast
GSK said that, if approved, the booster would enable those who received Bexsero as infants to take a single additional dose from age 10 onwards, a move company believes could help reduce the burden of invasive meningococcal disease in countries with established MenB infant programmes.
The FTSE 100-listed firm said the filing was backed by a Phase 3b, open‑label, multi‑centre study assessing immune responses in 10 to 20‑year‑olds who had completed the primary Bexsero series in infancy. The data showed a single booster dose effectively restored immune protection. Full results will be presented at the 25th International Pathogenic Neisseria Conference in September.
As of 0815 BST, GSK shares were down 0.37% at 1,909.50p.
Halifax is not responsible for the content and accuracy of the Markets News articles. We may not share the views of the author. Understand the risks, please remember the value of your investment can go down as well as up and you may not get back the full amount you invest. We don't provide advice so if you are in any doubt about buying and selling shares or making your own investment decisions we recommend you seek advice from a suitably qualified Financial Advisor. Past performance is not a guide to future performance.
