Delving into the Latest Updates on Nirsevimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-RSV MAb-YTE, Immunoglobulin g1, anti-(human respiratory syncytial virus fusion protein)(human monoclonal med18897 .gamma.1-chain), disulfide with monoclonal med18897 .kappa.-chain, dimer, Immunoglobulin g1-kappa, anti-(human respiratory syncytial virus fusion glycoprotein f0 (protein f))human monoclonal antibody.gamma.1 heavy chain (1-456) (human vh (homo sapiens ighv1-69*01(ighd)-ighj4*01 (90.1%)) (8.8.19) (1-126) -homo sapiens ighg1*03

+ [13]

Target

RSV F protein

Action

inhibitors

Mechanism

Respiratory syncytial virus F protein inhibitors

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Respiratory Syncytial Virus InfectionsPneumonia due to respiratory syncytial virusLower Respiratory Tract Infections

Inactive Indication-

Originator Organization

AstraZeneca AB

Active Organization

Sanofi Pasteur SA

Sanofi Winthrop Industrie SAAstraZeneca AB

+ [5]

Inactive Organization

MedImmune LLC

License Organization

Dr. Reddy's Laboratories Ltd.MedImmune Pharma BV

SK bioscience Co., Ltd.

+ [7]

Drug Highest PhaseApproved

First Approval Date

European Union (31 Oct 2022),

Pneumonia due to respiratory syncytial virus

RegulationBreakthrough Therapy (United States), Fast Track (United States), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Accelerated assessment (European Union), Promising Innovative Medicine (United Kingdom)

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Structure/Sequence

Sequence Code 64418264L

Source: *****

Sequence Code 315645337H

Source: *****

This study aims to evaluate the impact of Nirsevimab, a monoclonal antibody used for RSV prophylaxis, on reducing RSV- related hospitalizations. It will be conducted at 8 pediatric departments in Tuscany, Italy. First, a matched case-control study investigates the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations during the RSV epidemic season 2024-2025. Second, a descriptive study examines how the Nirsevimab immunization campaign affects RSV epidemiology, focusing on patients' age, comorbidities, infection severity, and clinical outcomes. The findings aim to optimize RSV prevention strategies and inform public health policies.

Start Date04 Dec 2024

Sponsor / Collaborator-

NCT06172660

/ RecruitingNot ApplicableIIT

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice. Some of the questions that the investigators hope to answer with this study are: 1) What is the overall effectiveness of these vaccines? 2) How long does immunity last? 3) How effective are the vaccines against new strains? 3) Does the vaccine's effectiveness vary by age?

Start Date01 Oct 2024

Sponsor / Collaborator

Yale University

[+1]

NCT06551506

/ RecruitingPhase 4IIT

A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVO (TM)), Infant Nirsevimab (BEYFORTUS (TM)) Immunization, or Both Products During the First Year of Life

Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children <5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined.

Start Date19 Sep 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Nirsevimab

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100 Translational Medicine associated with Nirsevimab

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100 Patents (Medical) associated with Nirsevimab

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258

Literatures (Medical) associated with Nirsevimab

31 Dec 2025·Human Vaccines & Immunotherapeutics

Respiratory syncytial virus immunization with nirsevimab: Acceptance and satisfaction assessment in infants and risk groups in the region of Murcia (Spain)

Article

Author: Sánchez Manresa, Susana ; del Pilar Ros Abellán, María ; Jesús Pérez Martín, Jaime ; de la Cruz Gómez Moreno, María ; Zornoza-Moreno, Matilde

Respiratory syncytial virus (RSV) is a leading cause of respiratory infections in infants under two years of age, often resulting in bronchiolitis and pneumonia, which contribute to high hospitalization rates. The recent approval of nirsevimab, a long-acting monoclonal antibody, has provided an immunization alternative for infants, addressing the substantial burden of RSV. This study aimed to evaluate acceptance and satisfaction among parents or legal guardians of infants who were candidates for immunization with nirsevimab in the Region of Murcia (Spain) during the 2023-2024 campaign. A cross-sectional survey, encompassing 1692 parents of immunized infants and 219 of non-immunized infants, revealed a high acceptance rate for nirsevimab, with 87% of parents indicating willingness to immunize a future child and 86.6% willing to recommend it. Concerns about safety and side effects were the primary reasons for hesitation among parents who did not immunize their infants. These findings underscore the importance of enhancing educational efforts in future campaigns to address safety concerns, thereby supporting broader RSV immunization coverage in the pediatric population.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of wastewater and environmental monitoring of respiratory syncytial virus to guide universal infant immunoprophylaxis in Canada

Article

Author: Paes, Bosco A. ; Rodgers-Gray, Barry S. ; Thampi, Nisha ; Delatolla, Robert ; Keary, Ian P. ; Mercier, Élisabeth ; Fullarton, John R.

AIMS:

To compare the cost-effectiveness of wastewater and environmental monitoring (WEM) versus clinical surveillance (CS)-guided respiratory syncytial virus (RSV) prophylaxis programs in Canada.

MATERIALS AND METHODS:

A cost-utility model was developed comprising two identical decision trees for RSV-WEM and RSV-CS. Within each tree, children could conservatively receive nirsevimab prophylaxis (71% coverage) or not at the start of the RSV season and subsequently experience an RSV-related hospitalization, medically-attended, non-hospitalized RSV-infection, or be uninfected/non-medically attended. All children could experience respiratory morbidity up to age 18 years, with higher rates following RSV-related hospitalization. All prophylaxis and RSV-related costs were identical for RSV-WEM and RSV-CS. No costs were assumed for RSV-CS; whereas a cost of CAD$12.31 per infant (infrastructure: CAD$4.07 plus sampling: CAD$8.24) was assumed if a new RSV-WEM system was initiated, with all infrastructure costs included in year 1. Predicated on data from the 2022-23 Ontario RSV season, RSV-WEM was assumed to provide a 15.1% benefit for earlier initiation of the prophylaxis program versus RSV-CS. Outcomes were modelled over an 18-year time horizon (1.5% discounting).

RESULTS:

RSV-WEM dominated (lower costs and higher utilities) RSV-CS and remained unaltered in all scenario analyses. Scenarios included: amortization of RSV-WEM infrastructure costs over 5 years; using existing WEM infrastructure for RSV detection; 25% reduction in extra cases identified by RSV-WEM; 50%-90% prophylaxis coverage based on real-world data; and 25% increase in the cost of RSV-WEM.

CONCLUSIONS:

The integration of RSV-WEM appears a highly cost-effective strategy (vs RSV-CS exclusively) to guide the earlier launch of RSV seasonal prophylaxis in Canada.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Health economic evaluation of implementing a universal immunization program with nirsevimab compared to standard of care for the prevention of respiratory syncytial virus disease in Canadian infants

Article

Author: Wu, Jianhong ; Shin, Thomas ; Kieffer, Alexia ; Greenberg, Michael ; Lee, Jason Kh

Respiratory syncytial virus (RSV) is a highly contagious pathogen and a leading cause of severe lower respiratory tract illness (LRTI) in infants and young children, irrespective of risk factors. Nirsevimab, an extended half-life monoclonal antibody, was approved in Canada in 2023 as a passive immunizing agent for the prevention of RSV LRTI. This study evaluated the optimal price per dose (PPD) at commonly accepted willingness-to-pay (WTP) thresholds among Canadian infants compared to the current standard of care (i.e. palivizumab for preterm infants and those with specific medical conditions). A static decision tree model was developed to assess the impact of nirsevimab on RSV-related health and economic outcomes among Canadian infants - including outpatient physician and emergency department visits, inpatient hospitalizations including intensive care unit (ICU) admissions and mechanical ventilation, and the associated healthcare costs of these outcomes. The model utilized Canadian epidemiological and cost inputs where possible, adopting a societal perspective. Compared to the standard of care, nirsevimab was expected to prevent 47,609 RSV-related health events, including 2,296 hospitalizations and a reduction of approximately $45 million in direct healthcare costs. At a WTP threshold of $50,000 per quality-adjusted life-year (QALY), the estimated base case PPD was $536, based on average cost assumptions across several costing scenarios. These findings suggest that universal immunization with nirsevimab could significantly reduce the health and economic burden of RSV among Canadian Infants.

265

News (Medical) associated with Nirsevimab

11 May 2025

·pharma.economictimes.indiatimes.com

Dr. Reddy Q4 net profit rises 22% but price erosion in US hit yearly earrings

Hyderabad: In the last quarter of fiscal year 2024-25 Dr. Reddy’s Laboratories posted a total revenue of ₹8,506 crore, with a 22 per cent growth in net profit on a year-on-year (YoY) basis to ₹1,594 crore. At a margin of 29 per cent the company’s Earnings Before Interest, Taxes, Depreciation, and Amortization (EBIDTA) for the quarter stood at ₹2,475 crore, reflecting a jump of 22 per cent against the corresponding quarter. For the full fiscal year the company's total revenue went up by 17 per cent to ₹32,554 crore and the net profit stood at ₹5,654 crore. “We achieved double-digit growth across our businesses, led by new product launches, increased revenues from key products in the US and the integration of the acquired NRT business, " said G V Prasad, Co-Chairman and MD, Dr. Reddy’s Laboratories. While the investors presentation of the company suggests that the quarter recorded highest ever EBITDA and revenue in FY25 but on a full year basis the drugmaker's net profit of ₹5,654 crore, reflects a marginal uptick of 2 per cent against the previous fiscal profit of ₹5,568 crore. This financial year, the company’s profit margin also reported a dip, standing at 17.6 per cent compared to 19.9 per cent in FY24. During the quarter all geographical arms reported a double-digit growth but the North America business — which accounts for nearly 40–45 per cent of the company’s total revenue — has seen an uptick of 9 per cent to ₹3,559 crore where the presentation notes that “demand-led growth is offset by price erosion.” However, in Q4 , North America generics sales showed a positive uptick of 5 per cent compared to the previous two quarters of the fiscal year where the company had reported a quarter-on-quarter (QoQ) contraction of 9 per cent (Q3) and 3 per cent (Q2) respectively. For FY25 the company's generics sales in the European market reported the largest uptick, growing by 75 per cent YoY to ₹3,588 crore. Some of the key highlights of the period includes the acquisition of Sanofi novel RSV drug, Beyfortus (nirsevimab) India marketing rights, partnership with Bio-Thera to commercialize ustekinumab and golimumab biosimilars, in Southeast Asia, among several other development. Besides this in Q2, last year the Indian drugmaker had acquired Haleon's global Nicotine Replacement Therapy (NRT) business for around ₹5,276 crore. Over the company’s future plans the MD said that, “we will continue to strengthen and grow our core businesses through portfolio management and operational excellence, while pursuing strategic partnerships and inorganic growth opportunities.” Currently in India the Hyderabad-based drugmaker stands at the 10th spot in terms of sales and has reported a growth of 8.4 per cent up against the 8 per cent gross domestic market growth. In FY25 the domestic generic sales went up 16 per cent YoY to d ₹5,373 core. During the fiscal the company's CAPEX reported a sharp boost to stand at ₹2,699 crore, up against ₹1,517 spent in the previous financial cycle. By Online Bureau ,

AcquisitionBiosimilarFinancial StatementDrug Approval

29 Apr 2025

·pharma.economictimes.indiatimes.com

Dr Reddy's to introduce Sanofi's novel drug in India

New Delhi: Dr Reddy's Laboratories on Monday said it has expanded its partnership with Sanofi Healthcare to introduce a novel drug for the prevention of lower respiratory tract disease in newborns. The company plans to introduce Beyfortus , which contains the monoclonal antibody, nirsevimab, in a prefilled injection used for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants. The medication is also administered in children up to 24 months of age, who remain vulnerable to severe RSV disease through their second RSV season. RSV is a highly contagious virus that can lead to serious respiratory illness in infants. Under the arrangement, Dr Reddy's will have exclusive rights from Sanofi to promote and distribute Beyfortus in India, the Hyderabad-based drugmaker said in a statement. The announcement follows Dr Reddy's successful exclusive distribution partnership with Sanofi for their portfolio of vaccines in India last year. Dr Reddy's is expected to launch Beyfortus in India in the second quarter of the current fiscal year. "Beyfortus enables the access of healthcare professionals and parents to an improved drug in the prevention of RSV," Dr Reddy's Laboratories CEO Branded Markets (India and Emerging Markets) MV Ramana said. Bringing Beyfortus to India is a pivotal step in the company's mission to protect every child from immunisation preventable diseases like RSV, Nitya Padmanabhan, Head of Sanofi Vaccines (India), said. Beyfortus has been approved for use in the European Union, the US, China, Japan, and many other countries around the world. In India, it received marketing authorisation approval in June last year from the Central Drugs Standard Control Organisation (CDSCO).

Drug ApprovalVaccineLicense out/in

24 Apr 2025

·pharma.economictimes.indiatimes.com

Sanofi's quarterly profit boosted by Dupixent and newer drugs; forecast unchanged

Bengaluru: France's Sanofi reported first-quarter profit that beat analysts' expectations on Thursday, boosted by strong demand for its anti-inflammatory drug Dupixent, as well as newer treatments and vaccines. However, the company left its full-year profit and sales forecasts unchanged, with Chief Financial Officer Francois-Xavier Roger flagging a "a volatile world where a number of things are difficult to predict." Sanofi results come as healthcare investors brace for potential tariffs by U.S. President Donald Trump on the sector after his administration announced probes into imports of pharmaceuticals. CFO Roger said at a press briefing that the company, which has been increasing its manufacturing presence in the United States, would consider more investments in the US, based on future needs. Drugmakers have argued that tariffs could increase the chance of shortages and reduce access for patients. In the quarter, business operating income, excluding one-off items, rose 20.1% to 2.90 billion euros ($3.29 billion), surpassing the average analyst estimate of 2.68 billion euros. Sanofi has ramped up research and development spending in recent years, prompting the company to abandon its long-term margin targets two years ago, as it seeks to build on the success of its blockbuster drug Dupixent and develop the next wave of growth drivers. "We stand by our strategic choice to invest significantly in our future with our R&D focus," Roger said. Sales of its blockbuster asthma drug Dupixent rose 20.3% to 3.48 billion euros, compared with 3.44 billion euros expected on average by analysts. Sales of Beyfortus, a new treatment to protect newborns from a common respiratory virus, jumped 54.9% to 284 million euros, compared with analysts' estimate of 215 million euros. ($1 = 0.8820 euros) (Reporting by Manas Mishra in Bengaluru; Editing by Nivedita Bhattacharjee and Sherry Jacob-Phillips)

Financial StatementBiosimilar

100 Deals associated with Nirsevimab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11380	-	-	DB16258

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	Canada	AstraZeneca Canada, Inc.	19 Apr 2023
Pneumonia due to respiratory syncytial virus	European Union	Sanofi Winthrop Industrie SA	31 Oct 2022
Pneumonia due to respiratory syncytial virus	Iceland	Sanofi Winthrop Industrie SA	31 Oct 2022
Pneumonia due to respiratory syncytial virus	Liechtenstein	Sanofi Winthrop Industrie SA	31 Oct 2022
Pneumonia due to respiratory syncytial virus	Norway	Sanofi Winthrop Industrie SA	31 Oct 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Respiratory Tract Infections	Phase 3	United States	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Japan	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Argentina	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Australia	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Austria	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Belgium	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Bulgaria	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Canada	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Chile	AstraZeneca PLC	23 Jul 2019
Lower Respiratory Tract Infections	Phase 3	Colombia	AstraZeneca PLC	23 Jul 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06180993 (NIRSE-GAL, Pubmed) Manual	Not Applicable	Respiratory Syncytial Virus Infections	10,259	nirsevimab	tmjmayfzkl(tmtmvsbilx) = vpefsktlan uqgkgrkcbx (ftvyhdwedg, 65.6 - 90.2) View more	Positive	30 Apr 2024
NCT03979313 (MELODY \| D5290C00004, CTgov)	Phase 3	Lower Respiratory Tract Infections \| Respiratory Syncytial Virus Infections	3,012	Placebo (Placebo)	mruhabfrib: Relative Risk Reduction (RRR) = 74.53 (95% CI, 49.63 - 87.12), P-Value = <0.0001 View more	-	28 Feb 2024
				MEDI8897 (Medi8897)
NCT04484935 (MUSIC, CTgov)	Phase 2	Respiratory Syncytial Virus Infections	100	Nirsevimab (Nirsevimab 50 mg/100 mg)	qkszrgoego = maqxljetyk bthhtgfcfg (xhqcnfminp, vhmmqhcbim - kucbkakzoj) View more	-	15 Nov 2023
				Nirsevimab (Nirsevimab 200 mg)	qkszrgoego = zncxvpgdkb bthhtgfcfg (xhqcnfminp, yxspxgsmbe - nxjdmwsvqt) View more
NCT04840849 (PK/ADA, CTgov)	Phase 1	-	24	nirsevimab (Nirsevimab)	kfgeshtnpn(yhocpgvaun) = ygvtnyxura slkxqppqfh (qnilealnql, NA) View more	-	02 Nov 2023
				Placebo (Placebo)	yvbzwbxvrb(omoflcsswc) = iraovrcujs lmbbcemjqg (pzycxkrcei, tczggtwqrf - kzndptntbg) View more
NCT03959488 (CTgov)	Phase 2/3	Respiratory Syncytial Virus Infections	925	MEDI8897 (MEDI8897)	oophctyuum = veiwxtmcih zrwhjlecuy (npnxtzzmsu, mkvehgdptt - jpwgpohgpz) View more	-	21 Sep 2023
				Palivizumab (Palivizumab)	oophctyuum = fzdxxxyipj zrwhjlecuy (npnxtzzmsu, uqzkrfukug - nxudprmnbw) View more
NCT03979313 (D5290C00004, FDA) Manual	Phase 3	Respiratory Syncytial Virus Infections	1,490	BEYFORTUS	oujnsbueuo(gymmgjpfls) = xidlwobudc hsrlnplrzd (razolccubu )	Positive	17 Jul 2023
				Placebo	oujnsbueuo(gymmgjpfls) = sdxtowqqdo hsrlnplrzd (razolccubu )
NCT02878330 (D5290C00003, FDA) Manual	Phase 2	Respiratory Syncytial Virus Infections	1,453	BEYFORTUS	wwzjkdswwm(emxudddnfi) = auhukpkdyl zoiralepee (djyntfgech )	Positive	17 Jul 2023
				Placebo	wwzjkdswwm(emxudddnfi) = dlwjbdligm zoiralepee (djyntfgech )
NCT03979313 (Pubmed \| N Engl J Med) Manual	Phase 3	Respiratory Syncytial Virus Infections	1,490	nirsevimab	clzfrcjspq(cqabhemkdz) = vhdtotiorz qprlhdablf (ahreazplqq ) View more	Positive	03 Mar 2022
				Placebo	clzfrcjspq(cqabhemkdz) = xbspynrleo qprlhdablf (ahreazplqq ) View more
NCT02878330 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 2	Respiratory Syncytial Virus Infections	1,453	Nirsevimab	vtxlvvsqgu(blruhgtvkc) = dxmpaagedp oajbcahnpj (yjgjbkdmac ) View more	Positive	30 Jul 2020
				Placebo	vtxlvvsqgu(blruhgtvkc) = shskeupcjy oajbcahnpj (yjgjbkdmac ) View more
NCT02878330 (MEDI8897 Ph2b \| D5290C00003, CTgov)	Phase 2	Lower Respiratory Tract Infections \| Respiratory Syncytial Virus Infections	1,453	Placebo (Placebo)	ebvonxwzlb = qboftmwbjt agcaupjsxk (mxvkmgthyj, dlsrnfgvyr - wohkcyzztw) View more	-	14 Oct 2019
				MEDI8897 (MEDI8897 50 mg)	ebvonxwzlb = gjzqzhukls agcaupjsxk (mxvkmgthyj, osaqrzgvcr - xjtydujtjk) View more

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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