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.
Chroma Medicine names new director
Medivir to present promising Fostrox data for liver lancer at ESMO Congress
TME Pharma to present NOX-a12 glioblastoma trial results at ESMO Congress 2024
Full-Life Technologies signs licence agreement with SK Biopharmaceuticals
Hoth Therapeutics adds three centres to clinical trial for cancer patients
SFA Therapeutics names new chief operating officer
Kyverna's KYV-101 granted FDA Regenerative Medicine Advanced Therapy designation