Europe Accelerates Long-acting RSV Antibody Assessment in Infants
France-based Sanofi and AstraZeneca announced the European Medicines Agency (EMA) had accepted the Marketing Authorization Application for nirsevimab under an accelerated assessment procedure on February 17, 2022.
Nirsevimab is the first investigational long-acting, single-dose antibody designed to protect infants against medically attended lower respiratory tract infections (LRTI) for their initial respiratory syncytial virus (RSV) season.
Nirsevimab is an immunization designed to provide direct prophylactic RSV protection to all infants via an antibody to help prevent LRTI caused by RSV.
Of note, monoclonal antibodies do not require the activation of the immune system to help offer rapid and direct protection against disease.
Nirsevimab is currently under clinical investigation, and its safety and efficacy have not been reviewed by any regulatory authority.
The EMA's accelerated assessment aims to reduce the timeframe to review an application and follows the EMA previously granting access to the PRIME scheme in 2019.
Jean-François Toussaint, Global Head of Research and Development Vaccines, Sanofi, commented in a press release, "RSV is a leading cause of hospitalization in all infants, and recent spikes in bronchiolitis and hospitalizations caused by RSV infection around the globe further demonstrate the need for a preventative option that can help protect all infants."
"We are pleased to receive this regulatory filing acceptance and remain confident in nirsevimab's potential to change the current RSV prevention paradigm as a possible single-dose option that may offer sustained protection to all infants for the season."
Nirsevimab has been granted regulatory designations to facilitate expedited development by several regulatory agencies, including, but not limited to, Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration and by the U.S. FDA.