AstraZeneca (AZ) and Sanofi’s Beyfortus (nirsevimab) has been recommended for conditional marketing authorisation (CMA) in the EU for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants, the companies announced.
If approved, the long-acting antibody would be the first broadly protective option for newborns and infants, including those born healthy, at term or preterm, or with specific health conditions.
The decision from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is based on positive results from the Beyfortus clinical development programme, including result from the MELODY phase 3, MEDLEY phase 2/3 and phase 2b trials.
The MELODY and phase 2b trials met their shared primary endpoint of Beyfortus reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season.
No clinically meaningful differences in safety results between the Beyfortus and placebo groups were seen, the companies noted.
In the MEDLEY phase 2/3 trials, Beyfortus also demonstrated a comparable safety and tolerability profile to Synagis (palivizumab), with adverse events reportedly similar between groups.
“This positive CHMP opinion underscores Beyfortus’ potential as a ground breaking, first-in-class passive immunisation that could transform the medical community’s approach to respiratory syncytial virus prevention in infants,” said Iskra Reic, executive vice president, vaccines and immune therapies, AZ.
RSV – a contagious virus characterised by several mild, cold-like symptoms – is the most common cause of LRTIs and is a leading cause of hospitalisation in all infants. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults, according to the Centers for Disease Control and Prevention (CDC).
In 2019, there were approximately 33 million cases of acute LRTIs, and more than three million hospitalisations worldwide. Moreover, it is estimated that acute LRTIs resulted in 26,300 in-hospital deaths of children younger than five years.
Jean-François Toussaint, global head of research and development vaccines, Sanofi, dubbed the recommendation “one of the most significant public health achievements in respiratory syncytial virus in decades”, adding it has “the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems”.