AstraZeneca Plc and Sanofi have achieved a significant milestone as their drug for Respiratory Syncytial Virus (RSV) in infants receives approval from the US Food and Drug Administration (FDA). This marks the first preventive treatment for RSV intended for widespread use against this common but dangerous virus in young children.
The timing of the FDA approval is crucial, as the RSV season in the US typically begins in the fall. However, in recent years, the virus has also surged during the spring and summer due to the impact of the Covid-19 pandemic, which has altered the timing of virus outbreaks.
The approved drug, named Beyfortus, is a long-acting monoclonal antibody specifically developed to prevent RSV infection in newborns and infants during their first RSV season. It is administered as a shot at birth if the baby is born just before or during the RSV season, which typically spans from October to March in the northern hemisphere.
Medical professionals and scientists have been searching for effective RSV vaccines and treatments for many years, as the virus leads to the hospitalization of thousands of children under the age of five in the US annually. RSV is particularly severe in infants and older individuals, resulting in an estimated 14,000 deaths among American adults each year.
Encouragingly, recent research breakthroughs have paved the way for the potential introduction of several new RSV prevention products in 2023. Last month, Pfizer Inc. and GSK Plc received support from a panel of US health advisers for their respective RSV vaccines, with the recommendation that these vaccines should be administered to individuals aged 60 and older after consultation with their doctors. Pfizer's vaccine is also currently awaiting approval for use in pregnant women to protect young babies.
Analysts predict that RSV prevention strategies for newborns in the US and EU could generate $1.3 billion in sales by 2032. This projected revenue would be shared between Pfizer's maternal vaccine and the medication developed by Sanofi and AstraZeneca.
While the approval has been granted, the Centers for Disease Control and Prevention (CDC) advisers will now determine the best utilization of Sanofi and Astra's drug. During a hearing in May, concerns were raised about the rate of preterm births in individuals who had received the Pfizer shot.
Regulators and government authorities must also decide whether both Pfizer's vaccine and the Astra-Sanofi antibody should be administered to pregnant individuals and their babies. An FDA advisory committee has already confirmed the efficacy of Pfizer's vaccine in preventing severe RSV for the first six months of a baby's life.
Prior to this recent breakthrough, AstraZeneca had developed an older RSV drug that acted as a form of immunization for infants at high risk of severe disease, notably premature babies. However, this antibody only provided short-term protection and required multiple injections.