GSK closes in on first ever RSV vax approval with UK nod

2023-05-01

临床结果临床3期突破性疗法优先审批疫苗

The European Medicines Agency’s (EMA) has recommended approval of GSK’s respiratory syncytial virus (RSV) vaccine candidate for use in older adults — lining up the drugmaker to have the first approved RSV vaccine in the world.

The positive opinion from EMA's Committee for Medicinal Products for Human Use (CHMP) marks the first time an RSV vaccine candidate for adults has gained a positive opinion — one of the final steps in the marketing authorization procedure prior to approval by the European Commission. There are currently no RSV vaccines approved anywhere in the world.

If approved, the vaccine will be used to prevent lower respiratory tract diseases (LRTD) caused by RSV in adult patients aged 60 and above.

The positive opinion is supported by data from the pivotal AReSVi-006 phase 3 vaccine efficacy trial. In the trial, the vaccine candidate showed 82.6% overall vaccine efficacy against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. Efficacy was 94.6% in older adults with at least one underlying medical condition of interest.

GSK expects the decision on EU marketing authorization by July 2023, which means U.S. approval may come first.

In November 2022, GSK received Priority Review from the U.S. FDA for its RSV vaccine candidate in older adults — giving the drugmaker a leg up with a regulatory action date of May 3, 2023. GSK’s jab was granted its designation based on results from the same AReSVi-006 phase 3 trial. In early March, an FDA advisory panel voted unanimously 12-0 on the vaccine's effectiveness and 10-2 on safety, teeing the candidate up for its May approval.

Pfizer is also awaiting a U.S decision this May. Back in December, the drugmaker announced that it had received Priority Review for its vax candidate, RSVpreF, which had also been granted Breakthrough Therapy designation earlier last year. The designation shortened the review period by four months, granting RSVpreF a May 31 PDUFA date.

Pfizer's vaccine, which uses crystal structure of prefusion F technology to target the viral fusion protein (F) that the virus uses to attack human cells, is being study for use in both older adults and pregnant women. In a phase 3 trial of 37,000 older adults, the vaccine showed 85.7% efficacy in reducing the risk of severe lower respiratory tract illness.

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