Bavarian Nordic’s MVA-BN RSV Receives the US FDA’s Breakthrough Therapy Designation for Prevention of Respiratory Syncytial Virus
Shots:
- The US FDA has granted BTD to MVA-BN RSV for active immunization to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged ≥ 60yrs.
- The designation is based on preliminary clinical evidence that demonstrate substantial improvement of MVA-BN RSV over available therapy on a clinically significant endpoint
- The company is planning to initiate a P-III study in 2022 and will work closely with the US FDA towards licensure of the vaccine
Ref: Globe Newswire | Image: CPhl Online
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