The approval was based on the finding from the Phase 3 trial in which Arexvy showed high overall vaccination effectiveness against RSV-LRTD, even in persons with specific underlying medical problems
GSK House in London, UK. (Credit: GSK plc)
Pharmaceutical major GSK announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised its Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD).
Arexvy is intended for active immunisation against respiratory syncytial virus (RSV) in adults 60 years of age and older.
The authorisation was supported by the results from the AReSVi-006 (Adult Respiratory Syncytial Virus) Phase 3 vaccine efficacy trial.
The randomised, placebo-controlled, observer-blind, multi-country trial assessed the efficacy of a single dose of GSK’s adjuvanted RSVPreF3 vaccine in 25,000 participants from 17 nations.
In the trial, high overall vaccination effectiveness against RSV-LRTD was observed, even in persons with specific underlying medical problems. In general, the vaccination was well tolerated.
GSK UK senior vice president and general manager Neale Belson said: “Our ambition is to help protect adults 60 years of age and older in the UK who are at risk from RSV disease, including those with underlying medical conditions, who drive the majority of RSV hospitalisations.
“This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation.”
The MHRA’s clearance follows the European Commission’s authorisation of Arexvy last month.
In a separate development, Elsie Biotechnologies signed a research collaboration agreement with GSK to advance oligonucleotide discovery technologies.
The partnership intends to accelerate the discovery and development of Elsie’s oligonucleotide discovery platform to find oligonucleotides optimised for safety, efficacy, and delivery.
The deal combines GSK’s expertise in DNA-encoded library technologies with Elsie’s drug discovery platform.
Initially, both firms will start a research period to assess the platform’s capabilities.
GSK may exercise an option for a non-exclusive licence from Elsie at any time throughout the research period to use the discovery platform and P(V) chemistry technology in its own oligonucleotide drug discovery research.
Elsie COO Kevin Green said: “This collaboration combines GSK’s expertise as leaders in the field of DNA encoded library technologies with the unique capabilities of Elsie’s scientists and discovery platform with P(V) chemistry with the goal to discover new RNA medicines.”