Drugs / Nirsevimab
Nirsevimab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed respiratory syncytial virus bronchiolitis 1 milestone | |||||
| Filed | US (FDA) | — | respiratory syncytial virus bronchiolitis | 2023-01-05 | “has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease” sanofi.com ↗ “AstraZeneca’s Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA)” astrazeneca.com ↗ “The FDA accepted the Biologics License Application (BLA) for nirsevimab in 2022” astrazeneca.com ↗ |
| Filed respiratory syncytial virus infectious disease 1 milestone | |||||
| Filed | EU (EMA) | — | respiratory syncytial virus infectious disease | 2022-02-17 | “AstraZeneca’s Marketing Authorisation Application (MAA) for nirsevimab has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA)” astrazeneca.com ↗ “The EMA has accepted the Marketing Authorization Application (MAA) for nirsevimab under an accelerated assessment procedure.” sanofi.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Beyfortus | — | 2022-10-31 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04840849 | Jun → Nov 2021 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02290340 | Jan 2015 → Sep 2016 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT02114268 | Apr 2014 → Jun 2015 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT04484935 | Aug 2020 → Feb 2023 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02878330 | Nov 2016 → Jul 2018 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03959488 | Jul 2019 → May 2021 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT07232706 | May 2026 → May 2029 expected | respiratory syncytial virus infectious disease | Centre Hospitalier Annecy Genevois | Recruiting | No outcome recorded |
| Phase 3 | NCT07041190 | Sep 2025 → Nov 2028 expected | respiratory syncytial virus infectious disease | PENTA Foundation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06042049 | Jul 2023 → Jul 2025 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT05437510 | Aug 2022 → Mar 2024 | respiratory syncytial virus infectious disease | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Phase 3 | NCT05110261 | Nov 2021 → Nov 2025 | viral respiratory tract infection | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03979313 | Jul 2019 → Mar 2021 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07578298 | Jun 2026 → Jul 2030 expected | respiratory syncytial virus infectious disease | Menzies School of Health Research | Recruiting | No outcome recorded |
| Phase 4 | NCT07158814 | Oct 2025 → Feb 2027 expected | — | Duke University | Recruiting | No outcome recorded |
| Phase 4 | NCT07109297 | Jul 2025 → Jun 2026 overdue | respiratory syncytial virus infectious disease | Sanofi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06551506 | Sep 2024 → May 2026 | respiratory syncytial virus infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 0 | NCT07106918 Comparator | Aug 2025 → Apr 2027 expected | respiratory syncytial virus infectious disease | Shanghai Institute Of Biological Products | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07363837 Comparator | Jan 2026 → Mar 2027 expected | respiratory syncytial virus infectious disease | Shanghai Institute Of Biological Products | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 39
| Date | Issuer | Release |
|---|---|---|
| 2026-02-16 | Sanofi | Results Press Release: Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season sanofi.com ↗
The study also showed 55.3% (95% CI 22.5-74.3) fewer hospitalizations in the second RSV season among infants who received a dose of Beyfortus during infancy. |
| 2025-05-29 | Sanofi | Results Press Release: Beyfortus public health advantage bolstered by first real-world comparison of infant vs maternal RSV immunization programs sanofi.com ↗
Late-breaking data show infant respiratory syncytial virus (RSV) hospitalizations reduced by 69% in Spain following Beyfortus-only immunization targeted to all infants and 26.7% in the UK following RSVpreF-only maternal vaccination |
| 2025-04-08 | AstraZeneca | Results AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025 astrazeneca.com ↗
Additionally, data being presented by our partner, Sanofi, confirm the significant public health impact and real-world effectiveness of Beyfortus in reducing RSV disease and hospitalisations in infants. |
| 2024-10-16 | AstraZeneca | Results AstraZeneca advances science of infectious disease protection at IDWeek 2024 astrazeneca.com ↗
Additional data, presented by our partner Sanofi, confirm the significant real-world effectiveness of Beyfortus in reducing RSV disease and hospitalisations in infants. |
| 2024-10-09 | Sanofi | Results Press Release: New Beyfortus data featured at IDWeek reinforce real-world effectiveness against RSV disease and hospitalization in infants sanofi.com ↗
In just the first year of implementation, Beyfortus has demonstrated high real-world effectiveness consistently exceeding 80%. |
| 2024-05-02 | Sanofi | Results Press Release: Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations sanofi.com ↗
Beyfortus reduced respiratory syncytial virus (RSV) hospitalizations by 82% (95% CI: 65.6 to 90.2) in infants under 6 months of age, compared to infants who received no RSV intervention, according to the interim results of an ongoing study published in The Lancet . |
| 2024-04-17 | AstraZeneca | Results AstraZeneca advances the science of infectious disease protection at ECCMID 2024 astrazeneca.com ↗
Real-world effectiveness data on Beyfortus reinforce the impact of passive immunisation protecting infants from RSV hospitalisation |
| 2024-03-27 | AstraZeneca | Regulatory Beyfortus approved in Japan for the prevention of RSV disease in infants astrazeneca.com ↗
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 respiratory syncytial virus (RSV) in all neonates, infants and children entering their first RSV season, and the prevention of RSV LRTD in neonates, infants and children at risk of serious RSV infection entering their first or second RSV season. |
| 2024-01-02 | AstraZeneca | Regulatory Beyfortus approved in China for the prevention of RSV disease in infants astrazeneca.com ↗
AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season. |
| 2023-10-11 | AstraZeneca | Results AstraZeneca reinforces commitment to protecting the most vulnerable from serious infectious diseases at IDWeek 2023 astrazeneca.com ↗
Nirsevimab is associated with higher and more sustained RSV neutralizing antibody responses compared with standard of care palivizumab: observations from a 2:1 randomised, phase 2/3 trial in medically vulnerable children (MEDLEY) |
| 2023-08-03 | Sanofi | Regulatory Press Release: U.S. CDC Advisory Committee unanimously recommends routine use of Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease sanofi.com ↗
Recommendation for use in all infants below 8 months of age follows earlier than anticipated FDA approval and unanimous FDA Advisory Committee vote |
| 2023-07-17 | Sanofi | Regulatory FDA approves Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease sanofi.com ↗
FDA approves Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease |
| 2023-07-17 | AstraZeneca | Regulatory Beyfortus approved in the US for the prevention of RSV lower respiratory tract disease in infants astrazeneca.com ↗ |
| 2023-06-08 | Sanofi | Regulatory Press Release: FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants sanofi.com ↗
The Committee also voted 19 to 2 in support of nirsevimab’s favorable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. |
| 2023-06-08 | AstraZeneca | Regulatory Nirsevimab unanimously recommended by FDA Advisory Committee for the prevention of RSV lower respiratory tract disease in infants astrazeneca.com ↗
The Committee also voted 19 to 2 in support of nirsevimab’s favourable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. |
| 2023-05-12 | Sanofi | Results Press Release: Nirsevimab delivers 83% reduction in RSV infant hospitalizations in a real-world clinical trial setting sanofi.com ↗
New data from the HARMONIE Phase 3b clinical trial show an 83.21% (95% CI 67.77 to 92.04; P<0.001) reduction in hospitalizations due to RSV-related LRTD in infants under 12 months of age who received a single dose of nirsevimab, compared to infants who received no RSV intervention. |
| 2023-02-21 | Sanofi | Results Media Update: Pediatric research at ReSViNET 2023 underscores Beyfortus’ potential to prevent RSV disease in infants sanofi.com ↗
These presentations strengthen Beyfortus’ consistency in demonstrating an efficacy of approximately 80% against medically attended RSV lower respiratory tract infections. |
| 2023-02-21 | AstraZeneca | Results ReSViNet 2023 data reinforce AstraZeneca’s commitment to help prevent Respiratory Syncytial Virus in infants astrazeneca.com ↗
Beyfortus continues to demonstrate consistent protection against RSV disease through the RSV season |
| 2023-01-05 | Sanofi | Regulatory Press Release: FDA accepts nirsevimab application as first protective option against RSV disease for all infants sanofi.com ↗
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. |
| 2023-01-05 | AstraZeneca | Regulatory Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months astrazeneca.com ↗ |
| 2022-11-04 | Sanofi | Regulatory Press Release: European Commission grants first approval worldwide of Beyfortus® (nirsevimab) for prevention of RSV disease in infants sanofi.com ↗
The European Commission has approved Beyfortus® (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. |
| 2022-11-04 | AstraZeneca | Regulatory Beyfortus approved in the EU for the prevention of RSV lower respiratory tract disease in infantsa astrazeneca.com ↗
AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. |
| 2022-10-20 | AstraZeneca | Results IDWeek data reinforces AstraZeneca’s commitment to advance science in vaccines and immune therapies astrazeneca.com ↗
Analysis of long-acting antibody Beyfortus across respiratory syncytial virus (RSV) season further underscores the potential of the investigational treatment to be the first and only single-dose preventative option for all infants |
| 2022-09-16 | Sanofi | Regulatory Press Release: CHMP recommends approval of Beyfortus® (nirsevimab) for prevention of RSV disease in infants sanofi.com ↗ |
| 2022-09-16 | AstraZeneca | Regulatory Beyfortus (nirsevimab) recommended for approval in the EU by CHMP for the prevention of RSV lower respiratory tract disease in infants astrazeneca.com ↗
AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been recommended for marketing authorisation in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. |
| 2022-05-11 | Sanofi | Results Press Release: New nirsevimab data analyses reinforce efficacy against RSV sanofi.com ↗
A prespecified pooled analysis of Phase 3 and Phase 2b data demonstrated an efficacy of 79.5% against medically attended lower respiratory tract infections (LRTI), including hospitalizations, caused by respiratory syncytial virus (RSV) |
| 2022-03-03 | Sanofi | Results Nirsevimab Shows 74.5% Reduction in RSV Infections in Phase 3 Trial sanofi.com ↗
Nirsevimab showed a 74.5% reduction in lower respiratory tract infections caused by RSV requiring medical care in healthy infants |
| 2022-03-03 | AstraZeneca | Results Nirsevimab significantly protected infants against RSV disease in Phase III MELODY trial astrazeneca.com ↗
Nirsevimab showed 74.5% efficacy against medically attended lower respiratory tract infections caused by RSV in healthy infants |
| 2022-02-17 | Sanofi | Regulatory Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants sanofi.com ↗
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for nirsevimab under an accelerated assessment procedure. |
| 2022-02-17 | AstraZeneca | Regulatory Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants astrazeneca.com ↗
AstraZeneca’s Marketing Authorisation Application (MAA) for nirsevimab has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the prevention of medically attended lower respiratory tract infections (LRTI) in all infants through their first respiratory syncytial virus (RSV) season. |
| 2021-10-28 | Sanofi | Results Sanofi: Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1) sanofi.com ↗
74.5% reduction in medically attended LRTI (Lower Respiratory Tract Infections) after 5 months of follow up. |
| 2021-06-28 | Sanofi | Results Press Release: Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial sanofi.com ↗
Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial |
| 2021-06-28 | AstraZeneca | Results Nirsevimab MEDLEY Phase II/III trial demonstrated favourable safety and tolerability profile in infants at high risk of RSV astrazeneca.com ↗
Occurrence of treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) were similar between groups. |
| 2021-04-26 | Sanofi | Results Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial sanofi.com ↗
Positive topline results from the Phase 3 MELODY trial showed nirsevimab reduced lower respiratory tract infections (LRTI) requiring medical attention (inpatient or outpatient) due to respiratory syncytial virus (RSV) in healthy preterm and term infants. |
| 2021-04-26 | AstraZeneca | Results Nirsevimab MELODY Phase III trial met primary endpoint of reducing RSV lower respiratory tract infections in healthy infants astrazeneca.com ↗ |
| 2020-07-30 | Sanofi | Results Positive Phase 2b Clinical Trial: Nirsevimab reduces lower respiratory tract infections by 70 percent sanofi.com ↗
Nirsevimab reduced respiratory syncytial virus (RSV) lower respiratory tract infections by 70 percent and related hospitalizations by 78 percent 1 |
| 2020-07-30 | AstraZeneca | Results Nirsevimab reduced respiratory syncytial virus infections and hospitalisations in preterm infants in Phase IIb trial astrazeneca.com ↗
On the primary endpoint, nirsevimab achieved a statistically significant 70.1% reduction in medically-attended RSV LRTI compared to placebo through 150 days post-dose. |
| 2019-02-05 | AstraZeneca | Regulatory US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897 astrazeneca.com ↗ |
| 2019-02-05 | AstraZeneca | Regulatory EMA grants PRIME eligibility for potential next-generation RSV medicine MEDI8897 astrazeneca.com ↗ |
All press releases naming this drug 45 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nirsevimab | “nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season” NCT06551506 ↗12“The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China” NCT05110261 ↗ “Nirsevimab” NCT07158814 ↗ |
| Known as | BEYFORTUS | “nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca” NCT06551506 ↗ |
| Known as | MED-18897 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297575 ↗ |
| Known as | MEDI8897 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03979313 ↗ |
| Known as | Nirsevimab (MEDI8897) | “Nirsevimab (MEDI8897)” NCT04484935 ↗ |
| Known as | nirsevimab-alip | “nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca” NCT06551506 ↗ |
| Modality | Monoclonal antibody | “MEDI8897 is a recombinant human RSV monoclonal antibody” PMID 27956428 ↗ Feb 2017 |
| Route | Intramuscular | “Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts.” NCT02114268 ↗ |
| Route | Intravenous | “Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts.” NCT02114268 ↗ |