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US FDA approval for shingles vaccine eyed by Glaxo

Monday, October 31, 2016 0:42
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London-listed drugs titan GlaxoSmithKline plc (LON:GSK) is applying for approval from the US Food & Drug Administration for a shingles vaccine targeted at the over-50s, it has emerged.

The effects of the illness, a reactivation of the latent chickenpox virus, can be excruciating and long-lasting and the risk of contracting it rises with age.

Shingrix, the name of the new GSK product, will undergo full regulatory scrutiny following the conclusion of a comprehensive and seemingly successful phase-III clinical study.

The results of the trial, released this time last year, revealed treatment had a near 90% efficacy rate in the over-70s.

Regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017.

“Shingles is a common and potentially serious condition,” said GSK’s head of vaccines, Dr Emmanuel Hanon.

“It can cause lasting pain and other complications such as scarring or visual impairment, which can severely impact the quality of people’s lives.

“The risk of developing shingles increases with age and it is estimated that up to one in every three people is at risk.

“Today’s file submission puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it.”

The drugs company updates the market on its financial performance on Wednesday with the figures set to show a solid, if unspectacular rise in revenues and earnings per share.

One of the major worries among investors is there aren’t enough potential blockbusters flowing from the Glaxo medicines pipeline to replace its best-selling asthma drug Advair, which has lost patent protection

Story by ProactiveInvestors


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