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GSK's Shingrix sails through FDA advisory committee

Shingles vaccine data proved safe and effective, says the panel

GSk

GlaxoSmithKline's blockbuster-in-waiting shingles vaccine Shingrix was backed for US approval by unanimous vote yesterday for use in people aged over 50.

The FDA panel voted 11 to zero that the data for the vaccine support the efficacy and safety of Shingrix for preventing shingles, setting up a market showdown with Merck & Co's Zostavax, currently the only shingles vaccine available.

Shingles is caused by the herpes zoster or varicella zoster virus (VZV), which causes chickenpox. While the immune system can generally shake off the symptoms of chickenpox, the virus lies dormant and if a person becomes immune-suppressed can reawaken, resulting in painful skin lesions. It is increasingly common with advancing age.

GSK is hoping that increased efficacy means it will be favoured ahead of Zostavax and also drive up vaccination rates against shingles, which remain relatively low. In June, the company reported the results of a trial which showed that Shingrix is effective in patients who had previously received Zostavax - widely regarded as being less protective - setting up the possibility of widespread use to prevent the painful and debilitating infection.

"The risk of developing shingles increases with age and it is estimated that up to one in three people in the US will develop shingles," said GSK's head of vaccines R&D Dr Emmanuel Hanon. The committee's vote "brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system", he added.

EvaluatePharma's latest World Preview report predicts that Shingrix will bring in worldwide product sales of $1.13bn in 2022, adding another blockbuster to GSK's vaccine portfolio alongside meningitis B shot Bexsero that is tipped to see sales double to $1.17bn in that year although its current growth has been checked by supply constraints.

Zostavax has been a big earner for Merck since its launch in 2006 and is expected to bring in more than $700m this year, but with revenues sliding as Shingrix starts to dominate.

Shingrix is a massively important product for GSK, which has acknowledged it has a weak late-stage pipeline and is implementing a turnaround plan under new CEO Emma Walmsley that is designed to deliver a new wave of products from 2022 onwards.

Article by
Phil Taylor

14th September 2017

From: Regulatory

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