Search Share Prices
GSK gets approval for Shingrix in Europe and Japan
GlaxoSmithKline announced on Friday 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.
The FTSE 100 drugmaker said the Japanese Ministry of Health, Labour and Welfare has also approved Shingrix for the prevention of shingles in adults aged 50 years or older.
It described Shingrix as a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses.
In Japan, the vaccine was registered to the Japan Vaccine Company, a joint venture of GlaxoSmithKline and Daiichi Sankyo.
GSK said 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.
"The approvals of Shingrix in Europe and Japan are recognition of the significant scientific advance this vaccine represents," said senior vice president and chief medical officer of GSK vaccines, Dr Thomas Breuer.
"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."
Dr Breuer said the risk and severity of shingles increased with age as the immune system lost 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 was 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, GSK claimed.
The approval of Shingrix followed 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 four years.
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.
GSK said the majority were mild to moderate in intensity and transient, generally lasting less than three days.
Shingrix was approved in the US and Canada in October last year, and had 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.
In a separate announcement on Friday, GSK also confirmed it was not longer interested in Pfizer's consumer helathcare business.