GlaxoSmithKline has submitted its shingles vaccine Shingrix for European marketing authorisation, following on the heels of its FDA filing last month.
The UK-based pharma firm 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.
The vaccine has already been touted for blockbuster sales, after clinical data demonstrated the drug’s greater efficacy in preventing shingles (herpes zoster) in older people than Merck & Co’s Zostavax jab.
In the phase III clinical trial programmes ZOE-50 and ZOE-70, which evaluated the safety, efficacy and immunogenicity of Shingrix in over 50s and over 70s, the vaccine had 90% efficacy and lasted for four years.
By contrast, Zostavax – currently the only shingles vaccine on the market – has an efficacy of between 18% and 70% and is both less effective and enduring in older people.
GSK’s vaccine also proved to reduce the overall incidence of postherpetic neuralgia, a form of chronic pain associated with shingles.
Dr Emmanuel Hanon, senior vice president and head of vaccines R&D at GSK, said: “GSK’s shingles candidate vaccine has consistently shown high efficacy in older people in its phase III development programme.
“[This] file submission puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it.”
A common but serious condition, shingles that results from the reactivation of the virus that causes chicken pox and can cause lasting pain and other complications.
The probability of developing the condition increases with age and it is that that up to one in every three people will develop shingles during their life.