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GSK's blockbuster hopeful Shingrix filed in US

Clinical data showed shingles vaccine had 90% efficacy in elderly patients

GlaxoSmithKline has filed its Shingrix vaccine candidate for the prevention of shingles in the US, and says applications in the EU and Canada will follow before year-end.

The vaccine is thought to be one of the brightest spots in GSK's near-term pipeline, with clinical data showing it is more effective in preventing shingles in older people than Merck & Co's older vaccine Zostavax.

Shingles is a painful infection caused by varicella zoster virus (VZV), the chickenpox virus. 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 Shingrix' efficacy profile means it will meet and exceed sales of Zostavax, which brought in $750m for Merck last year.

Last month, the UK pharma group reported clinical data showing that Shingrix had 90% efficacy in elderly patients, with the vaccine still providing protection four years after it was administered. In contrast, Zostavax' efficacy is generally between 18% and 70% and is known to decline in older people.

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.

"Shingles is a common and potentially serious condition [and] can cause lasting pain and other complications such as scarring or visual impairment," said GSK's head of vaccines R&D Dr Emmanuel Hanon. "The risk of developing shingles increases with age and it is estimated that up to one in every three people is at risk."

GSK needs Shingrix and other new products in its pipeline to deliver as it copes with increased competition in its respiratory business and the loss of patent protection for blockbuster asthma and chronic obstructive pulmonary disease (COPD) drug Seretide/Advair (salmeterol and fluticasone propionate).

Other important new products for the company include interleukin-5 inhibitor Nucala (mepolizumab) for severe asthma, sirukumab for rheumatoid arthritis, daprodustat for anaemia and HIV drug cabotegravir, a new product cycle that GSK says will add £6bn to its revenues by 2020.

Article by
Phil Taylor

25th October 2016

From: Regulatory



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