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GSK makes case for revaccination with Shingrix

The pharma giant seeks regulatory approval to treat people aged 50 plus


GlaxoSmithKline has reported positive results from a phase III trial that backs giving its Shingrix shingles vaccine to people who have already received an older but less effective live vaccine.

The new data was presented to the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) meeting yesterday, and could be instrumental in encouraging take-up of Shingrix, which was filed for approval in the US last November shortly after a marketing application was submitted in Europe.

The results of the Zoster-048 study met its primary objective of showing that people who had received the currently-approved vaccine - Merck & Co's Zostavax - at least five years previously showed no difference in the antibody response to Shingrix compared to an unvaccinated group.

GSK said the data "could eventually inform a policymaking decision regarding revaccination for protection against shingles with Shingrix", which has been tipped to become a blockbuster product on the strength of after clinical data demonstrated the drug's greater efficacy compared to Zostavax in preventing shingles - also known as herpes zoster.

In trials Shingrix has shown protective efficacy rates of 90% over at least four years, while Zostavax has efficacy of between 18% and 70%, performing less well in older people who also sees its protection wane over time. GSK's vaccine also proved to reduce the overall incidence of post-herpetic neuralgia, a debilitating form of chronic pain associated with shingles.

The UK-based pharma group is seeking regulatory approval for the treatment of people aged 50 years and over with two intramuscular doses, given at a two-to-six month interval. In addition to the US and EU marketing applications have been submitted in Canada and Japan.

"We are encouraged by these results, which indicate that Shingrix can be an option for adults over 50 years of age, who previously received the currently available vaccine and are seeking to benefit from revaccination," said Thomas Breuer, chief medical officer of GSK's vaccines unit.

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.

Zostavax meanwhile has seen revenues slide from around $750m in 2015 to $685m last year, which Merck has put down to a weaker flu vaccine season in the US which generally means fewer people get vaccinated in general, as well as reimbursement hurdles.

Article by
Phil Taylor

22nd June 2017

From: Regulatory



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