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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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Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Forxiga recommended in EU for patients with CKD


 
for the treatment of patients with chronic kidney disease
 
for millions of people in the EU suffering from chronic kidney disease
 
AstraZeneca s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).
 
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DAPA-CKD Phase III trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease (ESKD) and cardiovascular (CV) or renal death, compared to placebo. ....

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