Sanofi: MHRA Grants Promising Innovative Medicine Designation to Nirsevimab
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RSV is a contagious virus, and the most common cause of severe lower respiratory tract infections (LRTI) in infants and young children, resulting in over 30,000 hospitalisations per year in the UK due to RSV-associated LRTIs for children under five years
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Promising Innovative Medicine (PIM) Designation was granted based on non-clinical and clinical data of nirsevimab in healthy preterm infants
Nirsevimab does not have a Marketing Authorisation (MA) in the UK for any indication
FOR MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY
The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) Designation to nirsevimab, an extended half-life monoclonal antibody (mAb) being investigated as a passive immunisation for the prevention of lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in all infants in their first RSV se