(BRIEF) AstraZeneca and Sanofi welcome the approval of Beyfortus (nirsevimab) in Japan through the Ministry of Health, Labor and Welfare to avoid decreasing respiratory tract disease (LRTD) caused by syncytial virus (RSV) respiration in newborns, infants and children entering their first or second RSV season. This milestone marks the availability of the first life-saving option for a giant RSV LRTD infant population, adding full-term and premature infants in good physical condition, as well as those with express fitness conditions. The approval is based on knowledge from physically powerful clinical trials demonstrating the efficacy and protection profile of Beyfortus, which promises to alleviate the burden of RSV disease in Japan and in vulnerable pediatric populations.
(PRESS RELEASE) CAMBRIDGE, March 27, 2024 — /EuropaWire/ — AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in Japan for the prophylaxis of lower respiratory tract disease (LRTD) caused by syncytial virus (RSV) in all newborns, infants and young people entering their first RSV season, and the prevention of RSV LRTD in newborns, infants, and youth with threat of severe RSV infection upon entering their first or second RSV season. 1 Beyfortus is expected to be in place for the upcoming 2024/25 RSV season, in accordance with existing Japanese guidelines.
Beyfortus is the first preventative option developed for a giant RSV LRTD infant population, adding ion for full-term or premature infants in good physical condition, or with express physical condition situations that make them vulnerable to serious illness. The approval from Japan’s Ministry of Health, Labor and Welfare is based on three key late-stage clinical trials of Beyfortus. Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV LRTD for five months, the duration of a typical RSV season. 2-5
In Japan, more than 100,000 cases of LRTD RSV are reported in infants each year, including healthy full-term infants. 6
Dr. Hiroyuki Moriuchi, professor and head of the Department of Pediatrics at Nagasaki University’s Graduate School of Biomedical Sciences, said, “This is a vital milestone in the fight against RSV in infants. Almost all children are affected by RSV before their 15th birthday. Two, and all babies, including those born full-term and healthy, would likely be at risk. RSV places a significant burden on young people, their families, and the medical system, which can also lead to long-term consequences of serious illness. Infection in early childhood. Beyfortus can protect babies from RSV season and its approval represents a very vital contribution to the prevention and control of RSV disease in Japan.
Iskra Reic, Executive Vice President, Vaccines and Immunotherapy at AstraZeneca, said: “The approval of Beyfortus means that it is imaginable for the first time to save severe respiratory illnesses caused by RSV in all infants in Japan and decrease the burden of infectious diseases. in health care systems. Beyfortus reflects AstraZeneca’s commitment to safe clinical progression of functions to help the most vulnerable patient populations and we look forward to Beyfortus being available in Japan by the 2024/25 season. “
Beyfortus has obtained approval from the European Union, the United States and China.
Remarks
o Babies born before 28 weeks gestation and 12 months of age
o Infants born between 29 and 35 weeks of gestation and older than 6 months of age.
o Newborns, infants, or children younger than 24 months who have been treated for chronic lung disease within the past 6 months.
o Newborns, infants, or children younger than 24 months with hemodynamically significant congenital central disease
o Newborns, infants or young people under 24 months of age with immunocompromised diseases
o Newborns, infants, or young people younger than 24 months with Down syndrome
The dosing regimen of Beyfortus was decided based on further exploration of Phase IIb knowledge and has been used in subsequent trials as a single dose of five 0 mg for those weighing less than five kg, or a single dose of one hundred mg for those weighing less than five kg. those weighing five kg or more1, 4.
The Phase III MELODY study (Trial 04) was a randomized, double-blind, placebo-controlled trial conducted in 21 countries and designed to evaluate the efficacy of Beyfortus compared to medically monitored LRTIs up to 150 days post-dose, compared with the placebo. in healthy subjects and expired premature infants. Infants (gestational age 35 weeks or more) entering their first RSV season. 1-3
The MEDLEY trial (Trial 05), a phase II/III, randomized, double-blind, controlled trial of Synagis (palivizumab), whose number one objective is to compare the protection and tolerability of Beyfortus in preterm infants less than 35 weeks gestational age and infants with central congenital disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible for Synagis. Between July 2019 and May 2021, a total of 925 infants entering their first RSV season were randomly assigned (2:1) to each of the preterm and CLD/CHD cohorts to receive either Beyfortus or Synagis. A total of 262 children younger than 24 months from the CLD/CHD cohort continued the trial during a second RSV season. Safety was assessed by monitoring the occurrence of adverse events up to 360 days after dosing.
Results from the MELODY, MEDLEY Phase II/III, and Phase IIb trials demonstrate that a single dose of Beyfortus is helping to protect infants in their first RSV season against RSV disease. This giant infant population includes premature babies born at term, expired preemies, and fit preemies. , as well as infants with express physical condition situations that make them vulnerable to severe RSV illness. 1,5
These trials formed the basis of regulatory filings that began in 2022.
Results
In a pre-specified secondary endpoint, Beyfortus reduced RSV with hospitalisation by 78. 4% (95% CI 51. 9, 90. 3) compared to placebo. The observed events were 0. 8% in the treatment group versus 4. 1% in the placebo group. 1 A body weight-based subgroup study indicated lower efficacy in infants weighing >5 kg compared with <5 kg. The post-hoc study resulting from the Phase IIb study implementing the recommended dose of 50 mg to a subgroup of infants weighing less than five kg showed that the efficacy of Beyfortus compared to LRTI for medically monitored RSV and medically accompanied RSV LRTI with hospitalization was 86. 2% (95% CI: 68. 0, 94. 0) and 86. 5% (95% CI 53. 5, 96. 1) respectively. 1. 7
The protection profile of Beyfortus is similar to that of Synagis in the Phase II/III MEDLEY trial and consistent with the protection profile in healthy term and preterm infants studied in the MELODY and Phase IIb trials. Although rare, the most commonly reported adverse reactions were: rash 14 days post-dose (most of which were mild to moderate); Non-serious injection site reactions within 7 days of administration. 1,3,5
Administration of Beyfortus may be scheduled at the beginning of the RSV season or the season for babies born in that season. 1
Beyfortus has received regulatory designations to facilitate accelerated progression through various primary regulatory agencies around the world. These come with breakthrough treatment designation and precedence review designation through the China Drug Evaluation Center under the National Medical Products Administration; U. S. Food and Drug Administration Breakthrough Therapy DesignationU. S. Citizenship and Drug the European Medicines Agency (EMA) programme (EMA PRIority MEdicines (PRIME)); and named “a drug for preceding progression” as a component of the Japan Agency for Medical Research and Development’s (AMED) Drug Improvement Project to promote the development of new drugs in pediatrics.
Following a review of the benefit-sharing agreement for the marketing of nirsevimab in the U. S. , the U. S. In the U. S. between AstraZeneca, Sanofi and Sobi, Sobi has entered into a direct relationship with Sanofi, replacing the previous stake agreement with AstraZeneca entered into in November 2018.
Beyfortus will be co-promoted through AstraZeneca and Sanofi in Japan.
References
1. Indication of the Ministry of Health, Labor and Welfare of Japan
2. Muller WJ, et al. Nirsevimab for the prevention of RSV in preterm and delinquent infants. N Engl J Med. 5 Apr 2023. DOI: 10. 1056/NEJMc2214773
3. Hammitt LL, et al. Nirsevimab for the prevention of RSV in healthy and delinquent preterm and term infants. N Engl J Med. 2022; 386 (9): 837-846. Doi: 10. 1056/NEJMoa2110275
4. Griffin P, MD et al. Single-dose Nirsevimab for the prevention of RSV in premature neonates. N Engl J Med. 2020; 383: 415-425. DOI: 10. 1056/NEJMoa1913556
5. Domachowske J, MD et al. Safety of nirsevimab for RSV in infants with heart, lung, or premature disease. N Engl J Med. 2022; 386 (9)
6. Ishiwada, N. et coll. Guidelines for the Treatment of Respiratory Infectious Diseases in Children in Japan 2022. The Pediatric Infectious Disease Journal. Volume 42, Issue 10, October 2023. DOI: 10. 1097/INF. 00000000000000041
7. Supplement to Simões EAF, et al. The efficacy of nirsevimab versus syncytial virus respiration decreases respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital central disease and chronic lung disease: a pooled review of randomized controlled trials. Lancet Child Adolesc Health 2023; online Jan. 9. https://doi. org/10. 1016/S2352-4642(22)00321-2.
Media Contact:
SOURCE: AstraZeneca
MORE ON ASTRAZENECA, ETC. : AstraZeneca’s Truqap is softened in Japan for complex breast cancer treatment. EQT Life Sciences’ portfolio company, Amolyt Pharma, has been acquired through Alexion, AstraZeneca Rare Diseases for $1. 05 billion. AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan Cancer Treatment Nears Approval for StraZeneca’s Advanced NSCLCA Treatment Tagrisso Shows Promise in Phase III LAURA Trial for EGFR-Mutated Lung Cancer FDA Approves AstraZeneca’s Tagrisso Plus Chemotherapy for EGFRA-Mutant Lung Cancer StraZeneca Advances in Cell Therapy with Acquisition of Gracell Biotechnologies While traZeneca Showcases Advances in Hematology and Long-Term Efficacy of Calquence at ASHA Annual Meeting Zeneca Evinova Launch: Pioneering Digital Health Solutions for the Advancement of Global Healthcare AstraZeneca’s Truqap Receives U. S. FDA approvalU. S. Department of Health for Advanced Breast Cancer Treatment
EuropaWire (EW) is, in fact, the first pan-European press release and press release distribution service for Europe and the European Union, which aims to consolidate Europe’s global voice of news agencies and the media. Submission forms, flexible PR pricing and budgets, granular targeting, unlimited maximum success across countries, markets, verticals, sectors, audiences, languages, etc. , translation and localization for greater local PR impact, detailed distribution, reporting, metrics. and insights, adding measured PR success, readings, interactions, impact, etc. , with no limits on words, images, and multimedia to accompany your post, among other things. Your press releases will be among the largest press releases and top vital companies, brands and establishments in Europe.
HOW DO I GET STARTED?