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(Alliance News) - AstraZeneca PLC on Thursday said nirsevimab, which is being developed in collaboration with Sanofi SA, has been accepted for accelerated review by the European Medicines Agency.
Nirsevimab is being assessed by the EU medicines body for the prevention of medically attended lower respiratory tract infections in all infants through their first respiratory syncytial virus season.
The marketing authorisation application is based on positive results from the Melody phase three trial, Medley phase two/three trial, and phase two b trial which demonstrated nirsevimab's safety and efficacy.
The EMA's Committee for Medicinal Products for Human Use granted nirsevimab accelerated assessment as it was deemed "of major interest for public health and therapeutic innovation", said AstraZeneca.
Accelerated assessment aims to reduce the timeframe for the CHMP to review an application compared to the standard procedure.
Shares in AstraZeneca were flat at 8,915.00 pence in London on Thursday, while Sanofi were down 0.6% at EUR92.97 in Paris.
By Lucy Heming; lucyheming@alliancenews.com
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