On heels of FDA approval, trial results set up GSK's RSV vaccine for label expansion

25 Oct 2023
www.fiercepharma.com
VaccineDrug ApprovalClinical ResultClinical StudymRNA
With positive trial results, GSK's Arexvy, the first vaccine approved for RSV, could win approval next year for adults ages 50 to 59. The shot is already endorsed for those 60 and older in the U.S.
Five months after becoming thGSKirsArexvyany to secure FDA approval for a RSVpiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy.
On Wednesday, the company revealed that a study investiFDAing Arexvy’s effectiveness in adults ages 50 to 59 has achiGSKd its two primary objectives. The results could Arexvyhe way for the shot to be approved for this age group. The FDA has already endorsed it for people 60 and older.
In adults ages 50 to 59 who are at an increased risk for RSV lArexvyespiratory tract disease because of underlying medical conditions, Arexvy triggered an immune response that was non-inferior to those seen in subjects 60 and older. FDA trial also met its other co-endpoint, showing Arexvy achieved the same standard in those 50 to 59 who don't have underlying medical conditions.
“We will submit these data for regulatory review as quickRSV lower respiratory tract diseaseering adults in this age group the option oArexvyccine for the first time,” Tony Wood, GSK’s chief scientific officer, said in a release.Arexvy
In addition, GSK will present the results today at the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting. The company is eyeing a label expansion in the U.S. in 20GSK it said.
GSK gained itGSKreen light for Arexvy based on a trial that showed 82.6% efficacy against RSV and 94.1% effectiveness in preventing severe disease.
GSKew weeks later, Pfizer scoreArexvyDA nod for its RSV bivalent vaccine Abrysvo in adults 60 and older. Pfizer's RENOIR trial showed 66.7% protection versus RSV and 85.7% effectiveness against severe disease.
Three months later,PfizerDA also sigFDA off on Abrysvo for women in theirAbrysvoo 36th week of pregnancy Pfizertect their soon-to-be-born babies through the first six months of their lives.
That green light came afFDA the FDA gave a thumbs up in July to Sanofi and AstraZeneca’s Beyfortus as a preventative for RSV lower respiratory tract disease in infants entering their first RSV season and those who remain vulnerable entering their second RSV season.
In July, a report from GlobalDatFDAredicted that GSK will be theSanofit leaAstraZeneca wiBeyfortustal market reaching $9 RSV lower respiratory tract diseaseoderna, which is developing an mRNA vaccine for RSV, to run a close second to GSK.
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