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Last update 15 Feb 2025
Felvizumab
Last update 15 Feb 2025
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms Felvizumab (USAN/INN), RSV monoclonal antibody, HuRSV19VHFNS/VK + [3] |
Target |
Mechanism Respiratory syncytial virus F protein inhibitors, Immunostimulants |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePreclinical |
First Approval Date- |
Regulation- |
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Related
100 Clinical Results associated with Felvizumab
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100 Translational Medicine associated with Felvizumab
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100 Patents (Medical) associated with Felvizumab
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58
Literatures (Medical) associated with Felvizumab01 Jan 2025·VACCINE
Economic burden of children hospitalized with respiratory syncytial virus infection in Spain, 2016–2019
Article
Author: López-Ibáñez de Aldecoa, A ; Sato, R ; Sarabia, L. ; Law, A.W. ; López-Ibáñez de Aldecoa, A. ; Aponte-Torres, Z. ; Ramirez Agudelo, J.L. ; Mora, L ; Haeberer, M. ; Mora, L. ; Ramirez Agudelo, J L ; Haeberer, M ; Seabroke, S ; Meroc, E. ; Aponte-Torres, Z ; Meroc, E ; Seabroke, S. ; Law, A W ; Sato, R. ; Sarabia, L
This retrospective observational study aimed to quantify the costs associated with hospitalized respiratory syncytial virus (RSV) in children <18 years admitted to the Spanish National Healthcare System between 2016 and 2019 and contrast them with the costs of unspecified bronchiolitis/bronchitis/pneumonia (UBP) and influenza. The mean cost per hospitalization episode was reported by age group, risk category and prematurity. Total annual hospitalization costs were calculated from population incidence rates and the mean cost per episode. A total of 41,934 children were hospitalized with RSV, 70,160 with UBP and 8525 with influenza during 2016-2019. The highest incidence of hospitalization for RSV, UBP, and influenza occurred among infants <6 months. The mean cost per episode was highest for RSV cases aged <6 months with at least one risk factor (€4760 high vs €2827 low risk), while the mean cost ranged from €3704-4352 for high-risk and €2687-3475 for low-risk children of other ages, and from €4300-44,594 for preterm infants. In the 0-5 months age group, the mean cost per episode for UBP was €4189 and €2666 for high and low risk, and for influenza it was €3134 and €2081, respectively; while the mean cost of co-infected RSV-influenza cases was €4809 and €2887, respectively. The mean total annual estimated cost for RSV for children aged 0-17 years was €39.3 M based only on reported cases, rising to €53.8 M if we correct for under-diagnosis and all RSV-attributable cases are considered. In contrast, the mean total annual cost for influenza was €5.9 M. Compared to influenza, RSV has a substantially higher economic burden; nevertheless, the Spanish immunization schedule recommends influenza vaccine between 6 and 59 months of age and RSV monoclonal antibody only for those aged <6 months. RSV immunization is still to be implemented in older children, considering that 37 % of RSV hospitalized patients were aged ≥6 months.
31 Dec 2024·Human Vaccines & Immunotherapeutics
Exploring parental perspectives: Maternal RSV vaccination versus infant RSV monoclonal antibody
Article
Author: Treston, Bryony ; Geoghegan, Sarah
Respiratory Syncytial Virus poses a significant global public health threat, particularly affecting infants aged less than one year of age. Recently, two forms of passive immunization against infant RSV have been developed and brought to market; nirsevimab a long-acting monoclonal antibody (mAb) and RSV-PreF, a maternal RSV vaccine. The acceptability and uptake of these products will play a pivotal role in determining the success of any national immunization strategy aimed at safeguarding infants from RSV. It is crucial at this time to reflect on the factors that influence parental decisions surrounding immunization to facilitate more informed discussions, enhance healthcare communication, and contribute to the design of effective RSV prevention strategies that resonate with the concerns and aspirations of parents worldwide.
01 Nov 2024·Infectious Diseases and Therapy
Respiratory Syncytial Virus Risk Profile in Hospitalized Infants and Comparison with Influenza and COVID-19 Controls in Valladolid, Spain, 2010–2022
Article
Author: Eiros, José M. ; Domínguez-Gil, Marta ; Atwell, Jessica E. ; Toquero-Asensio, Marina ; Atwell, Jessica E ; Liu, Qing ; He, Yongzheng ; Uppal, Sonal ; Mengel, Martin ; Sanz-Muñoz, Ivan ; Haeberer, Mariana ; Hernán-García, Cristina ; Fernández-Espinilla, Virginia ; Sanz, Javier Castrodeza ; Rojo-Rello, Silvia ; Eiros, José M ; Martin-Toribio, Alejandro ; Fan, Rong
INTRODUCTION:
We aimed to describe the risk profile of RSV infections among children aged ≤ 24 months in Valladolid from January 2010 to August 2022 and to compare them with influenza and COVID-19 controls.
METHODS:
We conducted a retrospective cohort study of all laboratory-confirmed RSV, influenza, and COVID-19 infections. We analyzed risk factors for RSV hospitalization and severity (length-of-stay ≥ 8 days, intensive-care-unit admission, in-hospital death or readmission < 30 days) and compared severity between hospitalized RSV patients vs. influenza and COVID-19 controls using multivariable logistic regression models.
RESULTS:
We included 1507 patients with RSV (1274 inpatient), 32 with influenza, and 52 COVID-19 controls. Hospitalized RSV (mean age 5.3 months) and COVID-19 (4 months) were younger than influenza (9.1 months) patients. Sixteen percent of patients had RSV within the first month of life. Most infants did not have comorbidities (74% RSV, 56% influenza, and 69% COVID-19). Forty-one percent of patients with RSV and influenza were coinfected vs. 27% COVID-19 (p = 0.04). Among RSV, hospitalization risk factors were prematurity (adjusted OR 3.11 [95% CI 1.66, 4.44]) and coinfection (2.03 [1.45, 2.85]). Risks for higher severity were maternal smoking (1.89 [1.07, 3.33]), prematurity (2.31 [1.59, 3.34]), chronic lung disease (2.20 [1.06, 4.58]), neurodevelopmental condition (4.28 [2.10, 8.73]), and coinfection (2.67 [2.09, 3.40]). Breastfeeding was protective against hospitalization (0.87 [0.80, 0.95]) and severity (0.81 [0.74, 0.88]), while complete vaccination schedule was protective against severity (0.51 [0.27, 0.97]). RSV had 2.47 (1.03, 5.96) higher risk of experiencing any severe outcome compared to influenza and did not show significant differences vs. COVID-19.
CONCLUSIONS:
RSV hospitalizations were more frequent and severe than influenza, while severity was comparable to the early pandemic COVID-19. Currently, both influenza and COVID-19 vaccines are included in the maternal and childhood Spanish immunization schedule between the ages of 6 and 59 months. RSV monoclonal antibody is recommended for ≤ 6 months but a third of patients were aged 6-24 months. Maternal RSV vaccination can protect their children directly from birth and indirectly through breastfeeding.
2
News (Medical) associated with Felvizumab05 Feb 2025
On February 4, Merck & Co. announced its 2024 financial results, revealing total revenue of $64.168 billion, marking a 7% increase year-on-year. The pharmaceutical segment alone generated $57.400 billion, also reflecting a 7% growth. However, research and development (R&D) spending dropped significantly to $17.938 billion, a decline of 41%.
In a concerning trend, revenue from the Chinese market fell by 20% to $5.394 billion, representing 9.4% of Merck's global pharmaceutical sales. Despite these challenges, Merck's flagship product, Keytruda (pembrolizumab), set new sales records, achieving $29.482 billion in revenue, an 18% increase that accounted for nearly 46% of the company’s total revenue.
As Keytruda continues to thrive, Merck is actively working to maximize its clinical and commercial value. This includes expanding early indications, exploring combination therapies, and developing a subcutaneous formulation. In November 2024, the subcutaneous formulation's Phase III study was successfully completed, reducing administration time to just 2-3 minutes compared to intravenous infusion.
Other oncology products also performed well, with the world’s first HIF-2α inhibitor, Welireg, generating $509 million in sales, up 133% year-on-year. This drug received approval in China in November 2024. Additionally, Lynparza (olaparib) contributed $1.311 billion to the revenue.
Merck's HPV vaccine, Gardasil/Gardasil 9, reported sales of $8.583 billion, a 3% decrease from the previous year. The decline was largely attributed to reduced demand in China, exacerbated by intense competition from domestic nine-valent vaccines and price wars involving two-valent HPV vaccines. In response, Merck has begun targeting the male market for HPV vaccination. In January 2025, Gardasil was approved in China for use in males aged 9-26, marking it as the first HPV vaccine approved for this demographic.
Merck has also been proactive in updating its vaccine portfolio. In June 2024, it launched the 21-valent pneumococcal conjugate vaccine, Capvaxive, enhancing its product lineup alongside Pneumovax 23 and Vaxneuvance.
In the cardiovascular sector, the new pulmonary arterial hypertension (PAH) drug Winrevair has emerged as a star product. Approved in March 2024, it has quickly generated $419 million in sales within its first year. The drug has also been submitted for approval in China.
Looking ahead, Merck is optimistic about its pipeline, which includes oral PCSK9 inhibitors and dual agonists for GLP-1R/GCGR expected to yield critical research data in 2025. The company is also ramping up efforts in infectious diseases and ophthalmology, with Clesrovimab submitted for U.S. approval as a single-dose RSV monoclonal antibody.
Merck's business development activities have intensified, particularly in China, with several strategic acquisitions aimed at expanding its innovative capabilities. These include a $700 million acquisition of CD3/CD19 bispecific antibodies and a $588 million agreement for a PD-1/VEGF bispecific antibody project.
Robert M. Davis, Merck’s Chairman and CEO, expressed confidence in the company’s long-term growth potential, stating, “Our strong growth in 2024 reflects the market demand for our innovative product portfolio, including Keytruda, Winrevair, and our robust animal health business.” Looking forward to 2025, Merck anticipates global sales between $64 billion and $65.6 billion.
Drug ApprovalAcquisitionPhase 3VaccineFinancial Statement
18 Jul 2023
Akosua Mireku
@AkosuaMireku1
Prior to Beyfortus’ approval, the only approved RSV preventative antibody treatment for infants was AbbVie’s Synagis (palivizumab). Credit: GOLFX via Shutterstock
The US Food and Drug Administration (FDA) has
approved
AstraZeneca
and
Sanofi’s
Beyfortus (nirsevimab), a form of passive immunisation for infants born during or entering their first
RSV season
.
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The therapy can also be given to infants up to 24 months of age who are vulnerable to severe RSV disease through their second RSV season.
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Beyfortus is an intramuscular monoclonal antibody therapy that acts by neutralising the RSV-F protein. This prevents the unfolding of the protein, blocking viral entry.
The antibody’s approval is based on data from three clinical studies (trials 03, 04 and 05) and a
positive recommendation
from a 9 June FDA Advisory Committee meeting. The
European Medicines Agency
approved the prophylactic treatment in October 2022. Regulatory authorities in China, Japan and several other countries are also assessing the therapy.
Prior to Beyfortus’ approval, the only approved RSV preventative antibody treatment for infants was
AbbVie’s
Synagis (palivizumab), which was approved in 1998. However,
AstraZeneca
’s newly approved medicine is the first preventative option that specifically protects the broad infant population through its first RSV season.
In a
February 2023 email interview
with
Pharmaceutical Technology
, Nancy Jaser, a senior infectious disease analyst at GlobalData, predicted that upon its approval, Beyfortus would replace Synagis as the standard of care passive immunisation for paediatric RSV patients.
Beyfortus’s approval follows the FDA approval of the
first RSV vaccine
for older adults,
GSK’s
Arexvy. Patients aged 60 years and above are eligible to take the immunisation. This was followed a few weeks later by approval for
Pfizer’s
RSV vaccine Abrysvo, intended for the same population of individuals aged 60 years and above.
Phase II data from Trial 03 (NCT02878330) demonstrated that infants treated with Beyfortus had a 6.9% lower incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI). It also demonstrated that Beyfortus decreased the risk of MA RSV LRTI by approximately 70% relative to placebo. In the
Phase III (MELODY) Trial 04
(NCT03979313), this increased to 75% efficacy compared to placebo. Data was taken from the
Phase II/III (MEDLEY) Trial 05
, showing that the drug had a favourable safety profile.
GlobalData is the parent company of
Pharmaceutical Technology.
According to GlobalData, the only other RSV monoclonal antibody antiviral in Phase III trials is
Merck’s
clesrovimab.
Merck
is investigating the drug in a Phase II/III (NCT04767373) and a Phase III (NCT04938830) study.
In a press release
, AstraZeneca’s executive vice president Iskra Reic said: “Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the US.”
Free Report
How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Access the report to:
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector.
Download the full report to understand what to expect and how to align your strategies for success.
By GlobalData
Submit
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UK (+44)
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Angola (+244)
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Armenia (+374)
Aruba (+297)
Australia (+61)
Austria (+43)
Azerbaijan (+994)
Bahamas (+1242)
Bahrain (+973)
Bangladesh (+880)
Barbados (+1246)
Belarus (+375)
Belgium (+32)
Belize (+501)
Benin (+229)
Bermuda (+1441)
Bhutan (+975)
Bolivia (+591)
Bosnia Herzegovina (+387)
Botswana (+267)
Brazil (+55)
Brunei (+673)
Bulgaria (+359)
Burkina Faso (+226)
Burundi (+257)
Cambodia (+855)
Cameroon (+237)
Canada (+1)
Cape Verde Islands (+238)
Cayman Islands (+1345)
Central African Republic (+236)
Chile (+56)
China (+86)
Colombia (+57)
Comoros (+269)
Congo (+242)
Cook Islands (+682)
Costa Rica (+506)
Croatia (+385)
Cuba (+53)
Cyprus North (+90392)
Cyprus South (+357)
Czech Republic (+42)
Denmark (+45)
Djibouti (+253)
Dominica (+1809)
Dominican Republic (+1809)
Ecuador (+593)
Egypt (+20)
El Salvador (+503)
Equatorial Guinea (+240)
Eritrea (+291)
Estonia (+372)
Ethiopia (+251)
Falkland Islands (+500)
Faroe Islands (+298)
Fiji (+679)
Finland (+358)
France (+33)
French Guiana (+594)
French Polynesia (+689)
Gabon (+241)
Gambia (+220)
Georgia (+7880)
Germany (+49)
Ghana (+233)
Gibraltar (+350)
Greece (+30)
Greenland (+299)
Grenada (+1473)
Guadeloupe (+590)
Guam (+671)
Guatemala (+502)
Guinea (+224)
Guinea - Bissau (+245)
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Haiti (+509)
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Hong Kong (+852)
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Indonesia (+62)
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Iraq (+964)
Ireland (+353)
Israel (+972)
Italy (+39)
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Japan (+81)
Jordan (+962)
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Korea South (+82)
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Libya (+218)
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Lithuania (+370)
Luxembourg (+352)
Macao (+853)
Macedonia (+389)
Madagascar (+261)
Malawi (+265)
Malaysia (+60)
Maldives (+960)
Mali (+223)
Malta (+356)
Marshall Islands (+692)
Martinique (+596)
Mauritania (+222)
Mayotte (+269)
Mexico (+52)
Micronesia (+691)
Moldova (+373)
Monaco (+377)
Mongolia (+976)
Montserrat (+1664)
Morocco (+212)
Mozambique (+258)
Myanmar (+95)
Namibia (+264)
Nauru (+674)
Nepal (+977)
Netherlands (+31)
New Caledonia (+687)
New Zealand (+64)
Nicaragua (+505)
Niger (+227)
Nigeria (+234)
Niue (+683)
Norfolk Islands (+672)
Northern Marianas (+670)
Norway (+47)
Oman (+968)
Palau (+680)
Panama (+507)
Papua New Guinea (+675)
Paraguay (+595)
Peru (+51)
Philippines (+63)
Poland (+48)
Portugal (+351)
Puerto Rico (+1787)
Qatar (+974)
Reunion (+262)
Romania (+40)
Russia (+7)
Rwanda (+250)
San Marino (+378)
Sao Tome & Principe (+239)
Saudi Arabia (+966)
Senegal (+221)
Serbia (+381)
Seychelles (+248)
Sierra Leone (+232)
Singapore (+65)
Slovak Republic (+421)
Slovenia (+386)
Solomon Islands (+677)
Somalia (+252)
South Africa (+27)
Spain (+34)
Sri Lanka (+94)
St. Helena (+290)
St. Kitts (+1869)
St. Lucia (+1758)
Sudan (+249)
Suriname (+597)
Swaziland (+268)
Sweden (+46)
Switzerland (+41)
Syria (+963)
Taiwan (+886)
Tajikstan (+7)
Thailand (+66)
Togo (+228)
Tonga (+676)
Trinidad & Tobago (+1868)
Tunisia (+216)
Turkey (+90)
Turkmenistan (+7)
Turkmenistan (+993)
Turks & Caicos Islands (+1649)
Tuvalu (+688)
Uganda (+256)
Ukraine (+380)
United Arab Emirates (+971)
Uruguay (+598)
Uzbekistan (+7)
Vanuatu (+678)
Vatican City (+379)
Venezuela (+58)
Vietnam (+84)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Wallis & Futuna (+681)
Yemen (North)(+969)
Yemen (South)(+967)
Zambia (+260)
Zimbabwe (+263)
Country
UK
USA
Afghanistan
Åland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos Islands
Colombia
Comoros
Congo
Democratic Republic of
the Congo
Cook Islands
Costa Rica
Côte d"Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kuwait
Kyrgyzstan
Lao
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab Jamahiriya
Liechtenstein
Lithuania
Luxembourg
Macao
Macedonia, The Former
Yugoslav Republic of
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territory
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russian Federation
Rwanda
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and The South
Sandwich Islands
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
US Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
British Virgin Islands
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Kosovo
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Drug ApprovalClinical ResultPhase 3Vaccine
100 Deals associated with Felvizumab
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D04136 | Felvizumab | - | - |
R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Respiratory Syncytial Virus Infections | Phase 3 | US | - |
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Clinical Result
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
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