GSK application for Shingrix for shingles prevention in at-risk adults aged 18 and over accepted for review in China
London: GSK plc has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application of Shingrix (Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over at increased risk.
Recombinant Zoster Vaccine (RZV) is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses and was initially approved in 2019 by the NMPA to prevent shingles in adults aged 50 years and over.
Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression, as well as other chronic conditions such as COPD, diabetes, and asthma.
Shingles typically presents as a rash, with painful blisters across the chest, abdomen, or face. The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also experience post‑herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years. PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases from findings in various studies.
Globally, shingles will affect up to 1 in 3 people in their lifetime. A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression, as well as other chronic conditions such as COPD, diabetes, and asthma. It is estimated that there are approximately 6 million cases of shingles in China each year, with the incidence in people who are at increased risk, including people who are immunocompromised either due to disease or therapeutic treatment, being over three times higher than the general population.
The NMPA application is informed by six clinical trials in patients aged 18 years and over who had undergone recent blood-forming cells (stem cell) transplantation, kidney transplant, or have blood cancer, solid tumour, or HIV.
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