EMA Accepts Application for AstraZeneca’s Anti-RSV Antibody Nirsevimab.

The European Medicines Agency (EMA) has accepted AstraZeneca’s Marketing Authorisation Application (MAA) for Nirsevimab under an accelerated assessment procedure. Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose.

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Nirsevimab and Its Mode of Action

Nirsevimab is a highly potent monoclonal antibody (mAb) that neutralizes RSV by binding the RSV fusion (F) protein expressed on virions and infected cells. It has been engineered to have a long half-life, so that only a single dose is sufficient for the entire RSV season. 

Developed by AstraZeneca in collaboration with Sanofi using AstraZeneca’s proprietary YTE technology, Nirsevimab is aimed at preventing lower respiratory tract infections (LRTI) such as bronchiolitis and pneumonia in infants caused by the respiratory syncytial virus (RSV).

Nirsevimab works through passive immunization, whereby the antibody is given directly to an infant to help prevent RSV infection and offers immediate protection unlike active immunization. In active immunization, a person’s immune system is activated to prevent or fight infection through a vaccine, which can take weeks to develop protection.

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Positive Results from Late-Stage Trials 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted nirsevimab accelerated assessment as it was deemed of major interest for public health and therapeutic innovation. 

The MAA for Nirsevimab is based on positive results from the data obtained from the MEDLEY Phase II/III trial, the MELODY Phase III trial and the Phase IIb study which demonstrated nirsevimab’s safety and efficacy in providing protection against the virus for all infants with a single dose for the RSV season.

AstraZeneca’s  Executive Vice President, BioPharmaceuticals R&D Mene Pangalos said “Each year, respiratory syncytial virus causes seasonal epidemics of lower respiratory tract infections in infants and preventative options are currently limited to infants at higher-risk . We are excited that the EMA has accepted this regulatory submission under an accelerated assessment procedure, as nirsevimab has the potential to be the first immunization to offer protection for all infants against respiratory syncytial virus as shown by the extensive clinical trial programme.”

The company plans to make additional regulatory submissions and also publish the data from the MELODY and MEDLEY trials in a peer-reviewed journal in the coming future. 

Author

Arvind C. Shekhar