Biopharma company GSK plc (LSE:GSK) (NYSE:GSK) announced on Wednesday that it has received US Food and Drug Administration (FDA) approval for Arexvy (respiratory syncytial virus vaccine, adjuvanted), the world's first respiratory syncytial virus (RSV) vaccine for older adults.
Arexvy was approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and over.
The vaccine was shown to have an efficacy of 82.6% against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint of the pivotal AReSVi-006 phase III trial. Efficacy against severe RSV-LRTD, which is defined as an RSV-associated LRTD episode preventing normal, everyday activities, was 94.1%.
Arexvy is expected to launch in the United States before the 2023/24 RSV season.
A final regulatory decision is anticipated in Europe in the coming months. Regulatory reviews are also ongoing in Japan and several other countries.
Pfizer reports positive Phase 3 data for ABRYSVO in adults at risk for RSV disease
Clover Bio announces SCB-1019 vaccine candidate Phase I trial data in initial young adult cohort
Sanofi launches Verorab for rabies prophylaxis in UK
BioVaxys expands patent portfolio for DPX delivery platform and advances DPX SurMAGE
YS Biopharma repays USD40m loan facility
Kintara Therapeutics and TuHURA Biosciences to merge
VGXI names new chief accounting officer
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Valneva launches Phase 1 trial for next-generation Zika vaccine
Circio Holding ASA confirms licensing deal with IOVaxis Therapeutics in China and Singapore
Everest Medicines names new chief medical officer and chief product officer
Pfizer's PREVENAR 20 gains European Commission approval for paediatric pneumococcal vaccine