Recommended

New webinar with Fujifilm: Monocyte activation test (MAT): Insight into examining regulations and markets prospects
New webinar: The path to optimisation in pharmaceutical microbiology
Join our webinar: An alternative medium to support sterility testing using the Growth Direct® Rapid Sterility System
Discover more in our new application note: validating recombinant cascade reagents in 3 simple steps
news

RWE shows efficacy of nirsevimab for infant RSV

New real-world data “adds to the evidence that use of long-acting monoclonal antibody [nirsevimab] may prevent moderate to severe respiratory syncytial virus disease” in infants after single dose.

real-world data shows efficacy of nirsevimab for infant RSV

Infants under 12 months who received a single dose of monoclonal antibody (mAb) nirsevimab showed an 83.21 percent reduction in hospitalisations due to respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD), according to new real-world data from a Phase IIIb trial.

Results from the Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study were presented at 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. HARMONIE investigated the efficacy and safety of a single intramuscular dose of nirsevimab.

Real-world data

The real-world data “adds to the evidence that use of long-acting monoclonal antibody may prevent moderate to severe RSV disease after a convenient single dose,” Professor Peter Openshaw, Professor of Experimental Medicine at Imperial College London commented.

With the data having been collected in a real-world (RW) setting during the 2022-2023 RSV season, it was “gathered at a time when RSV was recovering from the dip in case numbers during COVID lockdown” Professor Openshaw added.

Thomas Triomphe, Executive Vice President of Vaccines at Sanofi shared: “The HARMONIE data demonstrate the real-world impact nirsevimab has on paediatric hospitalisations.” This is important, Professor Openshaw noted, because RSV is “the major single cause of hospitalisation in this age-group”.

FDA accepts Biologics License Application for RSV vaccine

The Phase III trial of the monoclonal antibody treatment

Over 8,000 infants were evaluated in the clinical trial. HARMONIE compared nirsevimab treatment to no intervention (standard of care). Nirsevimab, a long-acting antibody, is being developed jointly by Big Pharma companies Sanofi and AstraZeneca. Agreed in March 2017, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities.

Real-world data from the Phase IIIb trial showed that nirsevimab reduced the incidence of hospitalisations due to severe RSV-related LRTD by 75.71 percent”

Real-world data from the Phase IIIb trial also showed that nirsevimab reduced the incidence of hospitalisations due to severe RSV-related LRTD by 75.71 percent. The mAb demonstrated a reduction of 58.04 percent in the incidence of all-cause LRTD hospitalisation compared to infants who received no RSV intervention.

Throughout HARMONIE, nirsevimab maintained a favourable safety profile, consistent with the pivotal trial results. Participant follow-up will conclude at 12 months.