FDA approves AstraZeneca’s drug to prevent RSV in babies and young children
Betsy Goodfellow | July 18, 2023 | News story | Research and Development | AstraZeneca, FDA, Immunology, RSV, Vaccine, paediatrics
The US Food and Drug Administration (FDA) has announced that it has approved Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in neonates and infants born during or entering their first RSV season, and in children up to the age of 24 months who remain vulnerable to RSV through their second season.
Beyfortus is a monoclonal antibody with activity against RSV, with one dose expected to provide protection throughout the RSV season. The drug is administered as a single intramuscular injection prior to or during the RSV season.
The safety and efficacy of the drug is supported by three clinical trials, with the key measure of efficacy being the incidence of medically attended RSV lower respiratory tract infection, assessed 150 days after administration of the drug.
Possible side effects include rash and injection site reactions, and the drug should not be given to patients with a history of serious hypersensitivity reactions to any of its active ingredients or excipients.
John Farley, MD MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, commented: “RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year. Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the healthcare system.”
Betsy Goodfellow
Related Content
BioNet receives positive EMA opinion on new pertussis vaccine
BioNet has received a positive opinion from the Committee for Medicinal Products for Human Use …
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Recipharm offers manufacturing support to vaccine trial from ImmBIO and iiCON
Recipharm, a contract development and manufacturing organisation (CDMO), has successfully manufactured PnuBioVax, a new protein-based …
