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(Alliance News) - GSK PLC on Tuesday delivered a triple dose of positive updates on some of its leading products, Arexvy, Shingrix and Blencep.
The Brentford, London-based pharmaceutical company said the US Food & Drug Administration has accepted under priority review an application to extend the indication of its adjuvanted respiratory syncytial virus vaccine, Arexvy, to adults aged 50-59 who are at increased risk for RSV disease.
If approved, Arexvy would be the first vaccine available for this age group. Arexvy is currently approved in the US in adults aged 60 and over for the prevention of lower respiratory tract disease caused by RSV.
The application was supported by positive results from a phase III trial which evaluated the immune response and safety of the vaccine in adults aged 50-59.
Arexvy is the first approved RSV vaccine in the world, accepted by the US FDA in May, which was followed by Pfizer's Abrysvo in August. Moderna is also progressing its own RSV vaccine.
Last week, GSK reported 2023 sales for Arexvy of GBP1.24 billion. The drug has also been approved in the EU, Japan, the UK and Canada.
"Having only launched in [the second half], this vaccine can already claim blockbuster status," said Shore Capital analyst Sean Conroy.
There was good news for another of GSK's highly-touted products, the shingles drug, Shingrix.
The company said its regulatory application for the prevention of shingles in at-risk adults aged 18 and over had been accepted for review by China National Medical Products Administration.
Shingrix is already approved in China for adults aged 50 years and over and the application could expand to include adults with an increased risk of the disease.
Around six million cases of shingles are reported in China each year, with the incidence over three times higher for adults at increased risk compared to the general population.
In 2023, sales of Shingrix reached GBP3.45 billion, growing 16% annually, and GBP908 million in the fourth quarter, up 18% year-on-year.
GSK also reported positive trial data for its blood cancer drug, Blenrep.
The firm said the DREAMM-7 phase III trial showed a Blenrep combination nearly tripled median progression-free survival versus standard of care combination in patients with relapsed/refractory multiple myeloma.
The trial showed a 59% reduction in risk of disease progression or death observed in patients with Blenrep combination versus standard of care daratumumab combination.
In December, Europe's health regulator, the European Medicines Agency, stuck to its recommendation not to renew conditional approval for Blenrep, citing data that did not confirm its effectiveness.
Shares in GSK fell 0.2% at 1,660.00 pence in London on Tuesday morning.
By Jeremy Cutler, Alliance News reporter
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