Janssen has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults 60 or older.
The designation was based on clinical data with Janssen’s prophylactic RSV senior vaccine that “may demonstrate substantial improvement compared to available standard of care on a clinically significant endpoint,” announced the company.
The investigational prophylactic vaccine is currently in a Phase IIb proof of concept study to investigate the safety and efficacy of the vaccine against RSV 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, global therapeutic area head, vaccines, and managing director, Janssen Vaccines & Prevention.
He continued to say that the “Breakthrough Therapy Designation represents clear recognition of the transformative potential of this investigational RSV preventive solution,” and that the company “looks forward to working closely with the FDA throughout the course of the prophylactic RSV senior vaccine development programme.”
As a result of the designation, vaccine candidate is now eligible for all associated FDA features.
RSV is a highly prevalent, very contagious respiratory infection and a leading cause of bronchitis and pneumonia, affecting more than 64 million people each year worldwide. Because the symptoms of RSV can be difficult to distinguish from influenza or other respiratory infections, many who are infected with RSV may not be properly diagnosed.