Janssen announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for their investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults aged 60 years and older.
RSV is a highly prevalent and contagious respiratory infection. It is the most common cause of bronchitis and pneumonia and usually manifests with cold-like symptoms making it difficult to discern from influenza or various respiratory infections. There is currently no preventive vaccine or effective antiviral treatment available for adults aged 60 years and older.
The prophylactic RSV senior vaccine utilizes the Company’s adenovector platform (AdVac) to deliver the gene encoding for the fusion protein of RSV virus as an antigen. The designation was based on clinical data demonstrating substantial improvement using the prophylactic RSV senior vaccine compared with the available standard of care. The Company is currently investigating the prophylactic RSV vaccine in a phase 2b proof of concept study to evaluate the safety and efficacy of the vaccine in adults aged 65 years and older.
“With no preventive vaccines or effective antiviral treatments currently available, RSV remains a significant cause of illness in at-risk populations, particularly older adults,” said Johan Van Hoof, MD, Global Therapeutic Area Head, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica N.V. “This Breakthrough Therapy designation represents clear recognition of the transformative potential of this investigational RSV preventive solution. We look forward to working closely with the FDA throughout the course of the prophylactic RSV senior vaccine development program.”
For more information visit janssen.com.