FDA grants Breakthrough Therapy Designation for Janssen’s Investigational Prophylactic Vaccine

The FDA has granted Breakthrough Therapy Designation for Janssen’s investigational prophylactic vaccine for the prevention of respiratory syncytial virus, mediated lower respiratory tract disease in adults aged 60 years or older. RSV is a highly-contagious, potentially life-threatening respiratory infection that affects more than 64 million people each year worldwide. The approval came on the back of 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).
Johan Van Hoof, M.D., 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.”