Therapy Areas: Oncology
China accepts GSK's Shingrix application for at-risk adults
6 February 2024 -

Biopharmaceutical company GSK plc (LSE/NYSE: GSK) said on Tuesday that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application for Shingrix (Recombinant Zoster Vaccine or RZV) for preventing shingles in adults aged 18 and over at increased risk.

While Shingrix is already approved in China for those aged 50 and over, this application seeks to expand eligibility to all adults facing heightened shingles risk. With approximately six million annual shingles cases in China, the incidence is notably higher among at-risk individuals, including those immunocompromised due to disease or therapeutic treatment.

The application draws from 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.

Shingles, caused by the varicella-zoster virus, poses significant health risks, especially for individuals with conditions like COPD and diabetes, often leading to debilitating nerve pain known as post-herpetic neuralgia.