Janssen announces U.S. FDA breakthrough therapy designation for investigational prophylactic vaccine for the prevention of respiratory syncytial virus in older adults

Janssen

3 September 2019 - Janssen announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults aged 60 years or older. 

Older adults are among the populations at highest risk of developing RSV, a highly-contagious, potentially life-threatening respiratory infection that affects more than 64 million people each year worldwide.

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).

Read Janssen press release

Michael Wonder

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Michael Wonder