Nirsevimab Under EMA Accelerated Review: Single-Dose, Five-Month Protection Against RSV for All Infants

RSV-Respiratory Syncytial Virus

News on February 18, 2022 /BioValleyBIOON/ --AstraZenecaAstraZeneca and Sanofi recently announced jointly that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for nirsevimab and will review it through an accelerated approval process.As a single dose for all infants to prevent lower respiratory tract infections (LRTI) during the first Respiratory Syncytial Virus (RSV) season.Nirsevimab was co-developed by AstraZeneca and Sanofi.

Nirsevimab is the first long-acting antibody designed to provide RSV protection for all infants.Currently, nirsevimab is being developed as a single-dose for infants experiencing their first RSV season and for children at higher risk during their second RSV season.

Nirsevimab MAA is based on positive results from the MELODY Phase 3 trial, the MEDLEY Phase 2/3 trial, and a Phase 2b trial (NCT02878330).These trials confirmed the safety and efficacy of nirsevimab in providing protection for all infants through a single dose during the RSV season.

The EMA's Committee for Medicinal Products for Human Use (CHMP) has granted nirsevimab an accelerated assessment, as the drug is considered to have significant importance for public health and therapeutic innovation. Compared with the standard review procedure, the accelerated assessment aims to shorten the CHMP's review timeframe for the MAA and follows the Priority Medicines (PRIME) designation granted by the EMA in 2019.

The marketed product for preventing RSV in infants and young children, Synagis

Nirsevimab is a long-acting anti-RSV monoclonal antibody with an extended half-life, averaging (±SD) 59.3 days (±9.6 days). Clinical data show that after a single dose injection, 97.9% of infants had serum concentrations above the target 90% effective concentration threshold of 6.8 μg/mL on day 151; 91 days later, the mean serum concentration of nirsevimab showed a proportional decay without any non-linear signs.Nirsevimab, which uses AstraZeneca's proprietary YTE technology, is being co-developed by AstraZeneca and Sanofi as a passive immunotherapy with the potential to directly provide all infants with immunity through a single intramuscular dose, offering immediate protection against RSV throughout the RSV season.

RSV is a very common infectious pathogen that can cause seasonal epidemics of LRTI (including bronchiolitis and pneumonia). Globally, RSV is the leading cause of hospitalization in infants and young children.

Nirsevimab is the first potential passive immunotherapy for infants, which has been proven to provide sustained protection throughout the RSV season with a single intramuscular dose.To date, nirsevimab has received qualifications aimed at facilitating rapid development from multiple regulatory agencies worldwide, including Breakthrough Therapy Designation granted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China, and the United States...FDABreakthrough Therapy Designation granted by the FDA, Priority Medicines (PRIME) designation granted by the European Medicines Agency (EMA), and "Priority Development Drug" designation granted by the Japan Agency for Medical Research and Development (AMED).

The Advantages of Nirsevimab Over the Marketed Drug Synagis

Respiratory Syncytial Virus (RSV) is a common contagious virus that infects the respiratory tract and is the leading cause of acute lower respiratory tract infections (LRTI, mainly bronchiolitis and pneumonia) in infants and young children. Data shows that nearly all infants and young children will have at least one RSV infection before the age of 2, with infants under 6 months being the primary affected group. RSV is highly contagious and can spread through droplets or contact between people. The RSV epidemic season occurs annually from autumn to the following spring, with a typical RSV epidemic season lasting 5 months.

Nirsevimab is an RSV monoclonal antibody with an extended half-life, developed as a passive immunotherapy to prevent RSV-induced LRTI. The product aims to be used in a broader population of infants than the current standard of care, including: infants experiencing their first RSV season, and infants with congenital heart disease or chronic lung disease entering their first and second RSV seasons.

Nirsevimab is a passive immunotherapy that directly provides antibodies to infants to help prevent RSV.; Passive immunity is different from active immunity, which prevents or fights RSV infection by activating the human immune system through vaccines.Passive immunity can provide immediate protection, while active immunity takes weeks to develop protective effects.

In March 2017, AstraZeneca and Sanofi reached an agreement to develop and commercialize nirsevimab. According to the terms of the agreement, AstraZeneca leads all development activities and initial regulatory approvals, and retains production activities, while Sanofi will lead commercialization activities. (Bioon.com)

Source of the original text:Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants