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GlaxoSmithKline's Shingrix Shingles Vaccine Gets Chinese Approval

Thu, 23rd May 2019 17:14

LONDON (Alliance News) - GlaxoSmithKline PLC on Thursday said its Shingrix vaccine has been approved in China for the prevention of shingles in adults over 50 years old.

Shingles is caused by the reactivation of the same virus that causes chickenpox, with most adults over 50 having a dormant form of the virus. Symptoms of shingles include an itchy and often very painful rash on one side of the body, with symptoms usually lasting between two and four weeks.

Up to 30% of people who have shingles will continue to experience pain afterwards, lasting from anywhere between three months and several years. Around one in thee people will develop shingles in their lifetime and it currently affects almost three million adults in China every year.

The Shingrix approval follows its inclusion in a list of 48 'clinically urgently needed new medicines' in China chosen for expediated review. Introduction of the vaccine will begin in 2020 and will be phased so as to makes sure a reliable supply of the vaccine is available to all countries where it has launched.

Looking ahead, Glaxo plans to increase the supply of Shingrix over several years through investment in "significant capacity expansion". At present, the vaccine is licenced for use in the EU, Canada, Japan, Australia, and the US,

Thomas Breuer, senior vice president & chief medical officer of GASK Vaccines said: "Today's approval of Shingrix in China is recognition of the significant scientific advance this vaccine represents. In the pivotal studies the vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a disease that affects one in three people across the Asia-Pacific region. It can result in lasting pain and other complications which can severely impact the quality of people's lives.

"We welcome the Chinese government's progress to enable faster entry of new products into China and we look forward to working with the relevant agencies to bring the benefits of this vaccine to local communities."

Approval for Shingrix in China follows a phase three clinical trial of more than 38,000 people which showed an efficacy against shingles of more than 90%.

Shares in Glaxo closed up marginally at 1,571.60 pence on Thursday.

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