The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the initiation of its Phase 3 EVERGREEN study. The study will evaluate the efficacy, safety and immunogenicity of Janssen's investigational adult vaccine against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV), when compared with placebo in approximately 23,000 adults aged 60 years and older throughout North America and a selection of countries across Europe, Asia and the Southern Hemisphere.
The EVERGREEN study was initiated based on positive results from the Phase 2b CYPRESS study, the first large study evaluating the efficacy and safety of Janssen's investigational RSV vaccine against RSV-associated LRTD in vaccinated adults aged 65 and older in the United States.
Efficacy and immunogenicity data from the Phase 2b CYPRESS study will be presented at the virtual IDWeek 2021 taking place from September 29 – October 3 (Abstract #1106286).
Older adults are at high risk of developing a serious infection from RSV, a highly contagious, potentially life-threatening respiratory virus affecting more than 64 million people worldwide in a typical year, across all age groups.1
In September 2019, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Janssen's investigational RSV adult vaccine for the prevention of LRTD caused by RSV in adults aged 60 years or older. This was based on clinical data indicating the potential for substantial improvement compared to available standard of care on a clinically significant endpoint(s). In November 2020, the European Medicines Agency's Committee for Medicinal Products for Human Use designated Janssen's investigational RSV adult vaccine as eligible for the priority medicines (PRIME) scheme based on promising clinical data and an unmet need for a prophylactic option to prevent RSV in older adults.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.