Weekly Digest - 27 May-02 Jun 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 27 May-02 Jun 2023
May 31, 2023: ABRYSVO (IM) / Respiratory Syncytial Virus / Pfizer: Approved in the US
- US FDA has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine) for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older
- Approval is based on the data of approximately 37,000 participants from the pivotal Phase 3 clinical trial RENOIR evaluating the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older
- The vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness in adults (≥60 years of age), without evident safety concerns
- The vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness in adults (≥60 years of age), without evident safety concerns
- On March 24, 2022, FDA granted Breakthrough Therapy Designation for ABRYSVO for the treatment of RSV
- Pfizer anticipates supply availability of the vaccine by Q3 2023
