GSK Shingrix gets nod in China for adults aged 18 years and over with shingles
GSK plc has announced that the China National Medical Products Administration (NMPA) has approved Shingrix (GSK's Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over who are at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.
Shingles poses a significant health burden, with approximately six million cases per year in China. Besides advancing age, other factors can increase the risk of developing shingles, including immunodeficiency or immunosuppression with no other shingles vaccine approved for this population in China.
Shingles-associated pain is often described as aching, burning, stabbing or shock-like and can have a considerable impact on patients’ quality of life, e.g. affecting sleep, and ability to undertake activities of daily living including work. This approval expands the reach of GSK’s RZV, to ensure protection for those patients most vulnerable to shingles.
Sanjay Gurunathan, Senior Vice President, Vaccines and Infectious Diseases R&D, said, “This approval marks a critical milestone in expanding access to GSK’s RZV for those at a higher risk of what can be a disrupting and devastating disease. Through close collaboration with regulatory bodies, we continue to drive innovation that helps protect vulnerable patient groups and shifting the focus of healthcare systems towards preventing diseases, like shingles.”
The NMPA application was 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.
Shingrix (Recombinant Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over and in several countries and regions. RZV is also approved for adults aged 18 years or over at increased risk for shingles. It combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunisation that contributes to the challenge of protecting adults aged 50 and over from shingles. RZV is not indicated to prevent primary varicella infection (chickenpox). The use of RZV should be in accordance with official recommendations and local product label.
