Glaxosmithkline Regulatory News (GSK)

Issued: 23 March 2018, London UK

Shingrix approved in Europe and Japan for the prevention of shingles in adults aged 50 and over

· The only shingles vaccine to achieve ≥90% efficacy across all age groups studied*

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Commission has approved Shingrix for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in adults aged 50 years or older.[i] The Japanese Ministry of Health, Labour and Welfare (MHLW) has also approved Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years or older. Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses. In Japan, the vaccine is registered to the Japan Vaccine Co., Ltd., a joint venture of GlaxoSmithKline and Daiichi Sankyo Co., Ltd.

Shingles is caused by reactivation of the varicella zoster virus, the same virus that causes chickenpox. Nearly all adults over 50 have the shingles virus dormant in their nervous system, waiting to reactivate with advancing age.[ii]

Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: "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.

"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," he said.

Shingrix 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.

Approval of Shingrix follows a comprehensive Phase III clinical trial program evaluating its efficacy, safety and immunogenicity in more than 38,000 people. In a pooled analysis of the pivotal efficacy studies, ZOE-50 and ZOE-70, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups studied, as well as sustained efficacy over a follow-up period of 4 years.[iii],[iv] By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic nerve pain and the most common complication associated with shingles. The most common local side effects reported in the clinical trials were pain, redness and swelling at the injection site. The majority were mild to moderate in intensity and transient, generally lasting less than three days.[v] [vi]

Shingrix was approved in the US[vii] and Canada[viii] in October 2017 and has been recommended by the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices as the preferred vaccine for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older.[ix]

About Shingles

Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox. Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age.[x] As people age, the cells in the immune system lose the ability to maintain a strong and effective response to VZV reactivation.[xi]

Shingles typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks. The pain associated with shingles is often described as burning, shooting or stabbing.[xii] Even once the rash is gone, a person can experience post-herpetic neuralgia (PHN), pain lasting from at least three months up to several years. PHN is the most common complication of shingles, occurring in up to 30 percent of all shingles cases. [xiii]

Shingles affects approximately 1.7 million Europeans annually[xiv] - approximately 600,000 new cases are reported in Japan each year.[xv] Older adults and those with conditions that compromise the immune system have the greatest risk for developing shingles. More than 99 percent of those over 50 years old are infected with VZV and, it is estimated that around one in three people will develop shingles in their lifetime.[xvi]

About Shingrix

Shingrix [Herpes Zoster vaccine (non-live recombinant, AS01B adjuvanted)] is a non-live, recombinant subunit vaccine to help prevent shingles (herpes zoster) in adults 50 years of age and older. The vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity that occurs as people age.[xvii] [xviii]i

Shingrix is to be given intramuscularly in two doses.

Important Safety Information for Shingrix

· You should not receive Shingrix if you are allergic to any of its ingredients or had an allergic reaction to a previous dose of Shingrix.

· The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.

· Vaccination with Shingrix may not protect all individuals.

Shingrix is not indicated for the prevention of chickenpox.

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