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GSK’s four-strain flu vaccine approved in Germany and UK

Will be sold as Influsplit Tetra in Germany and Fluarix Tetra in the UK

GSK's four-strain flu vaccine approved in Germany and UK

GlaxoSmithKline (GSK) has been granted marketing approval in Germany and the UK for its four-strain (quadrivalent) influenza vaccine, the first registered product of its type in Europe.

The new product contains two influenza A subtypes and two influenza B subtypes and will be sold as Influsplit Tetra in Germany and Fluarix Tetra in the UK, according to GSK. It has been cleared for use in adults and children over three years.

The go-ahead comes amid a gradual shift towards quadrivalent flu vaccines, which provide broader protection than the current trivalent products that protect against two influenza A subtypes and a single influenza B subtype.

Despite the best efforts of regulators and industry there has been some mismatch between the selected A and B strains in recent years, and a second B strain will reduce the risk of breakthrough cases.

"As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine," said GSK in a statement.

GSK launched its four-strain version in the US last December under the Fluarix Quadrivalent name, and with AstraZeneca/Medimmune's FluMist Quadrivalent already on the market, the upcoming flu season in the US is expected to see fairly widespread adoption of the new products.

Sanofi Pasteur also has its own candidate, Fluzone Quadrivalent, in late-stage development and could be ready to supply the 2013-14 season as the FDA action date for the application is June 10. In addition, Novavax is planning to start pivotal trials of its candidate later this year.

Meanwhile another flu vaccine stalwart, Novartis, seems to be lagging somewhat behind its peers as it has been concentrating its resources on the development of cell-based production techniques.

Benlysta enters phase III for vasculitis
Meanwhile, GSK said it had started a phase III trial of its lupus drug Benlysta (belimumab) in patients with ANCA (anti-neutrophil cytoplasmic antibodies) positive vasculitis, a condition characterised by inflammation of the blood vessels.

The study will examine whether Benlysta in combination with azathioprine can improve remission in ANCA-positive vasculitis patients.

GSK acquired Benlysta as part of its $3.6bn acquisition of Human Genome Sciences, but the product has been fairly slow to build momentum as a lupus treatment since its launch in 2011, racking up sales of £70m ($106m) last year.

4th April 2013

From: Sales, Healthcare

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