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Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Nirsevimab PhII/III trial confirms safety profile

and tolerability profile in infants at high risk of RSV

The MEDLEY Phase II/III trial evaluated the safety and tolerability of nirsevimab compared to Synagis (palivizumab) when given to infants at high risk of respiratory syncytial virus (RSV) entering their first RSV season.
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The trial assessed the safety of nirsevimab in infants with chronic lung disease (CLD), congenital heart disease (CHD) and/or prematurity. Occurrence of treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) were similar between groups.
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Nirsevimab is a long-acting antibody, using AstraZeneca s proprietary YTE technology, being developed by AstraZeneca and Sanofi with the potential ....

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Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial

Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial
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Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Nirsevimab Phase III trial met primary endpoint

Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Nirsevimab Phase III trial met primary endpoint
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Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial

Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial
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Sanofi: MHRA Grants Promising Innovative Medicine Designation to Nirsevimab

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 infan ....

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