GSK Announces MHRA Approval of Arexvy, the First RSV Vaccine for Adults Aged 60 and Older in the UK
GSK
Pharmaceutical R&D Manufacturer
Medicines and Healthcare products Regulatory Agency
The MHRA is an executive agency of the UK Department of Health and Social Care, responsible for ensuring that medicines and medical devices work effectively and are safe and reliable. Established in 2003 through the merger of the Medicines Control Agency and the Medical Devices Agency, the organization employs more than 1,300 staff members.
SmartCom APP learned that GlaxoSmithKline (GSK.US) announced on Monday that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the company's Respiratory Syncytial Virus (RSV) vaccine Arexvy for the prevention of lower respiratory tract disease (LRTD) caused by RSV infection in individuals aged 60 years and above.
In early May, Arexvy was approved for marketing by the U.S. Food and Drug Administration (FDA) for the prevention of RSV infection leading to LRTD in individuals aged 60 and above. According to statistics from the U.S. Centers for Disease Control and Prevention, RSV causes approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths annually among adults aged 65 and older. In early June, the vaccine also received approval for marketing from the European Commission.