Nirsevimab Granted Breakthrough Therapy Designation in China for RSV Prevention in Infants

Source: Yiyao Guanlan

According to the recent public announcement on the official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA), nirsevimab, a long-acting monoclonal antibody co-developed by Sanofi Pasteur and AstraZeneca for the prevention of respiratory syncytial virus (RSV) infection, has been officially approved for inclusion in the Breakthrough Therapy Designation program. Nirsevimab employs a passive immunity mechanism to prevent RSV-associated diseases and is indicated for all infants experiencing their first RSV season, as well as for children with chronic lung disease or congenital heart disease who are experiencing their first or second RSV season. The inclusion of nirsevimab in the Breakthrough Therapy Designation program is expected to accelerate the approval and market launch of the first RSV preventive medication in China.

Screenshot source: CDE official website

Nirsevimab is an extended-half-life prophylactic monoclonal antibody that utilizes a passive immunization mechanism. Infants and young children can rapidly acquire immunity against respiratory syncytial virus (RSV) with a single intramuscular injection, thereby gaining protection throughout the RSV epidemic season. According to the results of its Phase 2b clinical trial, a single intramuscular injection of nirsevimab administered to healthy preterm neonates prior to their first RSV epidemic season provides durable protection for up to five months, ensuring infants safely pass through the entire RSV epidemic season. The study results also demonstrated that nirsevimab significantly reduced medical visit rates and hospitalization rates due to RSV infection, by 70.1% and 78.4%, respectively, compared to the placebo saline control group.

It is reported that nirsevimab, a monoclonal antibody for the prevention of respiratory syncytial virus (RSV), had previously received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and was approved by the European Medicines Agency (EMA) for inclusion in its Priority Medicines (PRIME) scheme. In Japan, nirsevimab has been selected by the Japan Agency for Medical Research and Development (AMED) as a “Priority Development Drug” under its “Drug Selection Research Program to Promote the Development of New Pediatric Drugs.” In the United Kingdom, nirsevimab recently received the Innovative Licensing and Access Pathway (ILAP) Breakthrough Innovation designation from the Medicines and Healthcare products Regulatory Agency (MHRA).

Clinical studies of nirsevimab are currently underway in more than 30 countries worldwide. A Phase 3 clinical trial targeting healthy infants and young children in China is also set to launch soon. It is reported that Sanofi Pasteur and AstraZeneca are working to bring nirsevimab to the Chinese market.

Respiratory syncytial virus (RSV) is a common seasonal infectious virus that causes respiratory tract infections. It is the leading cause of lower respiratory tract infections in infants and young children, as well as the primary reason for hospitalization due to such infections in this population. Worldwide, nearly all children are infected with RSV before the age of two, and approximately 67%–79% of infants and young children hospitalized for RSV infection were previously healthy. It is estimated that annually in China, between 215,000 and 500,000 infants and young children are hospitalized due to RSV infection. Currently, there are no effective therapeutic drugs or preventive measures specifically targeting RSV-related diseases in China. Once infected, treatment for infants and young children remains primarily focused on symptom relief.

Professor Shen Kunling, Director of the National Clinical Research Center for Respiratory Diseases and affiliated with Beijing Children’s Hospital, Capital Medical University, stated, “There is currently a significant unmet medical need in the prevention and treatment of respiratory syncytial virus (RSV). If nirsevimab is ultimately approved for market launch, it will fill a major gap in the prevention of RSV-related diseases. We hope to initiate relevant clinical trials in China as soon as possible and secure early approval, so that all infants and young children in China can benefit.”

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