AstraZeneca PLC on Friday said its respiratory syncytial virus treatment Beyfortus, or nirsevimab, which it develops with Sanofi SA, has received EU approval for prevention of the virus in newborns and infants.
Cambridge, England-based AstraZeneca said: ‘Beyfortus is the first and only single-dose RSV passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.’
The approval was based on results from the antibody’s clinical development programme, including the Melody phase III trial.
The news follows a September recommendation for EU approval from the EU’s European Medicine’s Authority’s Committee for Medicinal Products for Human Use.
RSV is a common contagious virus affecting the lungs and breathing passages, with no vaccines currently available for treatment.
London-based pharmaceutical firm GSK PLC in June said it is close to developing the world’s first RSV vaccine. On Wednesday, GSK had said its RSV older adult vaccine candidate, which it estimates to be able to bring $4 billion annually in sales, has been granted priority review by the US Food & Drug Administration.
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