GSK’s shingles vaccine secures EU and Japan approvals

pharmafile | March 26, 2018 | News story | Sales and Marketing |  EU, Europe, GSK, Japan, Shingrix, pharma, shingles 

GlaxoSmithKline has announced that its shingles vaccine Shingrix has secured approval in two new regions: in Europe, for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in adults over 50 years old, and in Japan for the prevention of shingles in patients over 50.

According to the manufacturer, it is the first approved shingles vaccine to “combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.” 

In Japan, Shingrix will be sold under the Japan Vaccine Co, a joint venture between GSK and Daiichi Sankyo.

Shingles originates from reactivation of the varicella zoster virus, the same virus which causes chickenpox in children. Approximately 99% of over 50s carry the virus, while the condition is estimated to affect around 1.7 million in Europe each year, with 600,000 new cases reported annually in Japan.

“The approvals of Shingrix in Europe and Japan are recognition of the significant scientific advance this vaccine represents. It has shown over 90% efficacy across all age groups studied for the prevention of shingles, a painful and potentially serious disease that affects around one in three people,” explained Dr Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines. “The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome this decline and to help protect people over 50 as we get older.”

Shingrix is already available in the US and Canada, having been approved in both regions in October last year and identified by the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices as its preferred vaccine for preventing shingles in immunocompetent adults over 50.

Matt Fellows