Shingrix approved in China for prevention of shingles in adults

23 May 2019

GlaxoSmithKline (LSE: GSK) today announced that China’s National Medical Products Administration (NMPA) has approved Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years or older. Shingrix is a recombinant subunit adjuvanted vaccine given intramuscularly in two doses.

The approval is in response to last year’s inclusion of Shingrix on a list of 48 ‘clinically urgently needed new medicines’ in China designated for expedited review, reflecting the country’s prioritization of critical new prevention and treatment options, the UK pharma major stated.

In the NMPA announcement on May 22, China’s regulator said Shingrix ‘lacks comprehensive domestic epidemiological data, and whether the use of new adjuvants may lead to the risk of potential immune-mediated diseases,’ and this approval is conditional. It wants the company to conduct post-approval studies to update the product's China-specific data and to better understand the adjuvant's potential link to the disorders.

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