GSK has secured a label expansion for its respiratory syncytial virus (RSV) vaccine, Arexvy, from the US Food and Drug Administration (FDA) – broadening the jab’s commercial reach on American soil.
Through this new approval, Arexvy will be available as a preventative measure to non-pregnant adults aged between 18 and 49 years of age, provided they are at increased risk of developing RSV-associated lower respiratory tract disease (LRTD).
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The FDA based its decision on data from a global Phase IIIb trial (NCT06389487), which confirmed Arexvy’s non-inferiority in immune response across the 18 to 49 age range compared with that seen in patients over 60 in a separate Phase III study (NCT04886596).
Arexvy made its market debut in 2023 after becoming the first RSV vaccine to secure regulatory approval in the US – though the shot was originally indicated for the 60+ age demographic only. GSK later secured a label expansion for Arexvy into the 50-59 age category.
Since its original approval, Arexvy has encountered competition from both Moderna and Pfizer, as the two pharma companies have both secured regulatory approval for their RSV vaccines, mRESVIA and Abrysvo, across the entire high-risk adult market.
According to analysts at GlobalData, parent company of Pharmaceutical Technology, sales of all three vaccines will experience a downturn in the next few years due to shifting attitudes towards vaccines across the US. However, analysts expect Abrysvo to absorb the largest share of the RSV market in 2030 out of the three by bringing in $1bn for Pfizer. GlobalData predicts that Arexvy and mResvia will generate $938m and $502m in sales, respectively, in 2030.
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By GlobalDataGSK plans to expand Arexvy’s commercial footprint by submitting further applications for the vaccine to regulators across multiple geographies.
US vaccine policy evolves
Arexvy’s expanded label comes as the US government looks to alter vaccine policy across the country. In January 2023, the Centers for Disease Control (CDC) updated the routine childhood immunisation schedule, shrinking the recommended list down from 18 vaccines to 11. The RSV vaccine was one of the seven jabs the CDC removed from this schedule.
Now, the US health secretary, Robert F Kennedy Jr (RFK Jr), has plans to further reduce this list as he plans to remove seven of the 11 remaining shots on the routine list.
This shifting perception can also be observed in the FDA, as the agency’s Center for Biologics Evaluation and Research (CBER) previously declined to review Moderna’s seasonal influenza vaccine, mRNA-1010, due to concerns around the supporting trial’s design. The FDA later pivoted on this take, agreeing to review the drug after Moderna appealed the decision.
The FDA’s approval of Arexvy comes soon after FDA commissioner Marty Makary announced that Vinay Prasad would be leaving his post at the helm of CBER for the second time.
