GSK scored a pivotal Priority Review from the FDA for its RSV vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
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GlaxoSmithKline scored a pivotal Priority Review from the FDA for its respiratory syncytial virus (RSV) vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
With the review in hand, GSK’s vaccine candidate could be cleared for commercialization in May of next year. That would allow the company to have the medication in place ahead of the next flu and RSV season. There are currently no RSV vaccines for older adults approved anywhere in the world.
GSK’s RSV older adult vaccine candidate contains a recombinant subunit perfusion RSV F glycoprotein antigen that has been combined with its proprietary AS01E adjuvant.
If the FDA approves the Biologics License Application, GSK’s vaccine candidate could become the first such medicine aimed at protecting adults over the age of 60 from lower respiratory tract disease caused by respiratory syncytial virus.
RSV is a challenging issue for older adults. The virus can exacerbate existing pulmonary conditions such as asthma and chronic obstructive pulmonary disease and lead to pneumonia and death. RSV can also worsen chronic heart failure in older adults.
It is estimated that in the U.S., RSV leads to hospitalization of approximately 177,000 older adults each year. Of those, about 14,000 succumb to the virus. Globally, the number is higher, with about 420,000 hospitalizations and 29,000 deaths, GSK estimated.
GSK’s BLA is supported by positive, interim Phase III data from the AReSVi-006 trial that showed high overall vaccine efficacy against RSV lower respiratory tract disease (LRTD) in treated adults over the age of 60. GSK noted in its announcement that consistent vaccine efficacy was observed against LRTD in severe disease in multiple patient subgroups, including adults between the ages of 70 and 79 and adults with underlying comorbidities. Additionally, GSK noted that the data was also positive across both RSV A and B strains.
In addition to the early signs of efficacy, the vaccine demonstrated a favorable safety profile as well, the company announced last month.
The Phase III trial included approximately 25,000 patients from 17 different countries. Beyond the FDA, GSK is also eying potential approval of its vaccine in Europe and Japan.
RSV Race
Developing an RSV vaccine has become something of a horse race. Multiple companies, including Pfizer, Moderna, Janssen, AstraZeneca and more, have been focused on an RSV vaccine for numerous populations. Besides older adults, young children are particularly susceptible to the virus. With such a wide-open patient field, the RSV market is valued at an estimated $4 billion.
Earlier this year, Pfizer announced plans to submit its RSV vaccine candidate for older adults to the FDA. The company also posted positive late-stage data for an RSV vaccine administered to expectant mothers on Monday. As BioSpace reported, the trial data was so strong Pfizer was allowed to halt the study early and will submit its own BLA to the FDA by the end of the year.
GSK has also been assessing an RSV candidate for maternal administration. Earlier this year, though, the company ran into a snag and was forced to halt enrolment and vaccination in three paused clinical trials assessing its vaccine candidate in pregnant women.
