ASTRAZENECA PLC Beyfortus is anticipated to be available for the upcoming 2024/25 RSV season, in line with existing Japanese guidelines.
Beyfortus is the first preventive option developed to protect a broad infant population against RSV LRTD, including protecting those infants born healthy at term, or preterm, or with specific health conditions that make them vulnerable to severe disease. The approval by the
More than 100,000 cases of RSV LRTD in infants are reported every year in
Dr.
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies,
Notes
Japan Beyfortus indication1
The following groups of neonates, infants or children at risk of serious RSV infection entering their first or second RSV season, should meet at least one of the following criteria: In the early stage of first RSV season
Infants born at 28 weeks' gestation or earlier and less than 12 months of age
Infants born at 29 to 35 weeks' gestation and less than 6 months of age
In the early stage of first and second RSV season
Neonates, infants or children less than 24 months of age who have received one treatment against chronic lung disease within the past 6 months
Neonates, infants or children less than 24 months of age with hemodynamically significant congenital heart disease
Neonates, infants or children less than 24 months of age with immunocompromised conditions
Neonates, infants or children less than 24 months of age with Down syndrome
Global pivotal clinical trials
The Phase IIb (Trial 03) study was a randomised, placebo-controlled trial designed to measure the efficacy of Beyfortus against medically attended (MA) Lower Respiratory Tract Infection (LRTI) through 150 days post-dose. Healthy preterm infants of 29 to less than 35 weeks' gestational age were randomised (2:1) to receive a single 50mg intramuscular injection of Beyfortus or placebo regardless of weight.
The Beyfortus dosing regimen was determined based on further exploration of the Phase IIb data and was used in subsequent trials as a single 50mg dose for those who weigh less than 5kg, or a single 100mg dose for those who weigh 5kg or greater.
The MELODY Phase III study (Trial 04) was a randomised, double-blind, placebo-controlled trial conducted across 21 countries designed to determine efficacy of Beyfortus against medically attended LRTI through 150 days after dosing, versus placebo, in healthy term and late preterm infants (35 weeks gestational age or greater) entering their first RSV season.
The MEDLEY (Trial 05) was a Phase II/III, randomised, double-blind, Synagis (palivizumab)-controlled trial with the primary objective of assessing safety and tolerability for Beyfortus in preterm infants of less than 35 weeks gestational age and infants with congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible to receive Synagis. Between
The results of MELODY, MEDLEY Phase II/III and the Phase IIb trials demonstrate that a single dose of Beyfortus helps protect infants during their first RSV season against RSV disease. This broad infant population includes healthy term, late preterm and preterm infants, as well as infants with specific health conditions that make them vulnerable to severe RSV disease.
These trials formed the basis of regulatory submissions which began in 2022.
Results
Phase IIb trial (Trial 03)
The primary endpoint of the Phase IIb study was met, reducing the incidence of medically attended LRTI caused by RSV by 70.1% (95% CI: 52.3, 81.2) compared to placebo. The event rates were 2.6% in treatment arm vs 9.5% in placebo arm. Between
In a prespecified secondary endpoint, Beyfortus reduced medically attended RSV LRTI with hospitalisation by 78.4% (95% CI 51.9, 90.3) versus placebo. Observed events were 0.8% in treatment arm vs 4.1% in placebo arm.1 A subgroup analysis by body weight indicated a lower efficacy in infants >5 kg vs
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