AstraZeneca Submits Nirsevimab BLA in China for RSV Prevention in Infants

On May 12, the marketing application for AstraZeneca's Nirsevimab injection was accepted by the National Medical Products Administration.

On November 4, 2022, nirsevimab received its global first approval in the EU under the brand name Beyfortus, for use in newborns and infants to help prevent RSV lower respiratory tract infections during their first respiratory syncytial virus (RSV) season. This is the first and only single-dose passive immunization agent that can be widely applied to the infant population, including full-term or preterm healthy infants, as well as infants with special health conditions.

Beyfortus is a long-acting monoclonal antibody under research, designed for all infants. It can protect them from RSV disease through a single injection from birth to their first RSV season. It was jointly developed by Sanofi and AstraZeneca.

Beyfortus has received accelerated development designations from multiple regulatory agencies worldwide. These include the "Breakthrough Therapy Designation" granted by the CDE; the Breakthrough Therapy designation awarded by the FDA; the PRIority MEdicines (PRIME) scheme authorized by the EMA; the "Innovative Medicinal Product" designation granted by the UK's Medicines and Healthcare products Regulatory Agency (MHRA); and the "Priority Development Drug" status within the Japan Agency for Medical Research and Development (AMED) program aimed at promoting the development of new pediatric medicines.

Multiple studies have demonstrated the efficacy and safety of Beyfortus, including the Phase III MELODY, Phase II/III MEDLEY, and a Phase IIb clinical study.

The Phase IIb clinical study enrolled 1,453 infant subjects to evaluate the efficacy of Beyfortus (50mg) in preventing RSV-related lower respiratory tract infections requiring medical attention within 150 days after injection. The results showed that, compared with placebo,Beyfortus can reduce RSV-related lower respiratory tract infections requiring medical attention by 70.1% (95% CI: 52.3, 81.2).

The MELODY study enrolled 1,490 subjects to evaluate the efficacy of Beyfortus (50mg and 100mg) in preventing RSV-related lower respiratory tract infections requiring medical attention within 150 days after injection in healthy late preterm and term infants (gestational age ≥35 weeks) entering their first RSV season. The results showed that, compared with placebo,A single dose of Beyfortus can reduce RSV-related acute lower respiratory tract infection (such as bronchiolitis or pneumonia) visit rates by up to 74.5% (95% CI 49.6, 87.1; P<0.001).

Moreover, the pooled analysis results of the Phase III MELODY study showed that, compared with placebo, Beyfortus can reduce the risk of lower respiratory tract infections (such as bronchitis and pneumonia) requiring medical attention in full-term and preterm infants entering their first RSV season by79.5%(95% CI 65.9, 87.7; P<0.0001). In the pooled analysis, healthy preterm and term infants received the recommended dose of Beyfortus based on weight. The results showed that Beyfortus, at the recommended dose, achieved an efficacy rate of 77.3% (95% CI 50.3, 89.7; P<0.001) in reducing RSV-related lower respiratory tract infection hospitalization rates in healthy preterm and term infants by Day 151.

The Phase II/III MEDLEY study enrolled 918 subjects, with the primary objective of comparing the safety and tolerability of Beyfortus versus Palivizumab in premature infants, infants with congenital heart disease, and/or infants with chronic lung disease. The results showed that the safety and tolerability of Beyfortus were comparable to those of Palivizumab.

RSV is the most common pathogen causing lower respiratory tract infections in infants, including bronchiolitis and pneumonia. RSV is also the leading cause of global infant hospitalization, with the majority of hospitalizations occurring in healthy full-term infants. In 2019, among children under five years old worldwide, there were approximately 33 million RSV-related acute lower respiratory infection cases, resulting in over 3 million hospitalizations and an estimated 26,300 in-hospital child deaths. It is estimated that the global direct medical costs associated with RSV (including hospitalization, outpatient visits, and follow-up care) in 2017 amounted to 4.82 billion euros.

Currently, there are no drugs for the treatment or prevention of RSV in China. Advaccine’s RSV vaccine ADV110 has progressed to Phase II clinical trials, and the MVA-BN RSV vaccine introduced by Nuance Pharmaceuticals from Bavarian Nordic has been approved for clinical trials in China. Meanwhile, companies such as Ark Biosciences, Ascletis Pharma, and LianBio are focusing on developing therapeutic drugs for RSV. In March this year, GSK submitted a clinical trial application in China for its RSV vaccine GSK3844766A, which was approved for marketing by the FDA on May 3rd. On May 8th, the oral nucleoside antiviral drug Dihydroxy Bromide Remdesivir Maleate Powder for Suspension (VV116), developed by Suzhou Vanway Biomedical, was approved for clinical trials by the CDE, intended for the treatment of Respiratory Syncytial Virus (RSV) infection.

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