The FDA designates Johnson & Johnson (JNJ -0.2%) unit Janssen Pharmaceutical’s prophylactic respiratory syncytial virus (RSV) senior vaccine a Breakthrough Therapy for the prevention of RSV-mediated lower respiratory tract disease in adults at least 60 years old.
The candidate is currently in Phase 2b development in people at least 65 years old.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
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