GSK and Daiichi Sankyo JV submits NDA for candidate shingles vaccine in Japan
GlaxoSmithKline (GSK) and Daiichi Sankyo joint venture (JV) Japan Vaccine Co has submitted a New Drug Application (NDA) in Japan for candidate shingles vaccine, Shingrix.
The Shingrix vaccine is a non-live, sub-unit vaccine developed to prevent herpes zoster (shingles) and its complications in people above 50.
Shingles is a painful, itchy rash that develops on one side of the body due to the reactivation of latent chickenpox virus known as varicella zoster virus (VZV).
The candidate vaccine combines with glycoprotein E, a protein found on the surface of VZV, with an adjuvant system AS01B that enhances the immunological response to the antigen.
GSK Vaccines R&D senior vice-president and head Dr Emmanuel Hanon said: “Shingles is a common and often very unpleasant condition that can cause lasting pain and other serious complications such as scarring or visual impairment, which can severely impact the quality of people’s lives.
“The probability of developing shingles increases with age and it is estimated that up to one in every three people will develop shingles in their lifetime.
“GSK’s shingles candidate vaccine has been shown in Phase III trials to help prevent shingles in older people, addressing the challenge of decreasing immunity that comes with age.”
The regulatory submission for Shingrix is based on a Phase III clinical trial programme conducted on more than 37,000 people in 18 countries, including Japan.
The programme studied the efficacy, safety and immunogenicity of the vaccine.
The analysis of the results found that the candidate vaccine reduced the incidence of shingles and also the overall incidence of post-herpetic neuralgia (PHN), a form of chronic pain associated with shingles.
The JV sought the regulatory approval for the vaccine to be given intramuscularly in two doses.
GSK has previously applied for regulatory approval for this vaccine to the US Food and Drug Administration in October 2016 and to Canadian regulatory authorities and the European Medicines Agency in November 2016.
Image: Transmission electron microscopic (TEM) image of a Varicella (Chickenpox) Virus. Photo: courtesy of CDC/Dr. Erskine Palmer/B.G. Partin.