The Janssen Pharmaceutical Companies of Johnson & Johnson got the USFDA’s Breakthrough Therapy Designation for its investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)- mediated lower respiratory tract disease in adults aged 60 years or older.
As a result of being granted Breakthrough Therapy Designation, Janssen’s prophylactic RSV senior vaccine candidate is now eligible for all associated FDA features.
The FDA Breakthrough Therapy 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(s), Janssen said in the press release Tuesday.
Johan Van Hoof, Global Therapeutic Area Head, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica N.V. said: “With no preventive vaccines or effective antiviral treatments currently available, RSV remains a significant cause of illness in at-risk populations, particularly older adults. 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.”
The investigational prophylactic vaccine is currently in a Phase 2b proof of concept study to investigate the safety and efficacy of the vaccine against RSV in adults aged 65 years and older.