RSV Designations Reached All-Time High in 2022, Data Shows

Last year, a record 10 review designations for respiratory syncytial virus (RSV)-indicated were rewarded by global regulatory authorities. According to a report by GlobalData, the surge was a precursor for the RSV-marketed drug landscape in 2023, resulting in several novel drug launches, particularly in the field of preventative treatments. Once these drugs are launched, they can ultimately be marketed and commercialized.

Starting in 2014, the amount of RSV drug designations slowly increased before hitting a substantial surge in 2022. According to GlobalData’s study, the number of RSV designations awarded represented 150% over the previous year, with seven designations being rewarded by the FDA.

Image Credit: GlobalData

“A total of 90% of RSV-related designations in 2022 were granted to prophylactic drugs. Pfizer’s Abrysvo (RSV vaccine), GSK’s Arexvy (RSV vaccine, adjuvanted) and AstraZeneca’s Beyfortus (nirsevimab-alip) accounted for over half of these. These drugs were in the later stages of development (Phase II/ III), and were strong candidates for expedited approval,” said Jasper Morley, drugs intelligence analyst, GlobalData. “The upward trend in the number of review designations being granted in recent years, culminating in the record number in 2022, showcases the emphasis placed by regulatory authorities on preventative RSV measures. These designations have enabled the earlier approval of life-saving treatments, and GlobalData forecasts that the expedited approval timelines of such prophylactic treatments will assist in curtailing RSV hospitalizations and associated fatalities.”

Reference: Record number of RSV designations awarded in 2022, says GlobalData. GlobalData. October 27, 2023. Accessed October 27, 2023. https://www.globaldata.com/media/pharma/record-number-rsv-designations-awarded-2022-says-globaldata/#:~:text=In%202022%2C%20global%20regulatory%20authorities,virus%20(RSV)%2Dindicated%20drugs