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RSV Older Adult Vaccine Candidate from GSK Wins FDA Priority Review, PDUFA Date Set


GSK announced earlier today that the US Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for and granted Priority Review to its respiratory syncytial virus (RSV) older adult vaccine candidate.

Currently there no vaccines to protect adults aged ≥60 years from RSV infection-related lower respiratory tract disease which can be particularly dangerous in older adults—a population whose immunity has begun to wane and who may have underlying conditions such as chronic obstructive pulmonary disease, asthma, and chronic heart failure that can lead to severe outcomes, including death.

With an FDA Prescription Drug User Fee Act date now set for May 3, 2023, according to GSK, the shot could become the first vaccine against RSV available for this vulnerable adult age group.

The BLA is supported by positive, interim phase III data from GSK’s AReSVi-006 (Adult Respiratory Syncytial Virus) clinical trial which demonstrated overall vaccine efficacy of 82.6% against RSV-lower respiratory tract disease (LRTD) in adults aged ≥60 years, satisfying the trial’s primary endpoint, according to GSK.

A range of prespecified secondary endpoints were also consistently positive with efficacy of 94.1% in patients with severe RSV-LRTD, 94.6% in participants with comorbidities, and 93.8% in adults aged 70-79 years. Efficacy of the investigational vaccine against RSV-LRTD was consistent across RSV A and B subtypes (84.6% and 80.9%, respectively), findings consistent with the significant neutralizing antibody response seen against both variants, according to the company.

The early signs of efficacy were complemented by a favorable safety profile, the company said.

RSV in the US is estimated to lead annually to hospitalization of approximately 177 000 older adults, resulting in as many as 14 000 deaths.

The randomized placebo-controlled AReSVi-006 trial enrolled 25 000 participants from 17 countries to evaluate efficacy of a single dose of the adjuvanted RSVPreF3 OA investigational vaccine in adults aged ≥60 years.

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