{"id":"rsvpref-mdv","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Atazanavir","action":"Monitor","effect":"Increased risk of atazanavir decreased concentrations"},{"drug":"CYP3A4 inhibitors","action":"Monitor","effect":"Increased risk of RSVpref-mdv decreased concentrations"},{"drug":"CYP3A4 inducers","action":"Monitor","effect":"Increased risk of RSVpref-mdv increased concentrations"},{"drug":"CYP3A4 substrates","action":"Monitor","effect":"Increased risk of CYP3A4 substrates decreased concentrations"},{"drug":"Ritonavir","action":"Monitor","effect":"Increased risk of ritonavir decreased concentrations"},{"drug":"Tipranavir","action":"Monitor","effect":"Increased risk of tipranavir decreased concentrations"}],"contraindications":["Hypersensitivity to the active substance or to any of the excipients","Severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine","History of anaphylaxis to a previous dose of RSVpreF-MDV or any component of the vaccine","Immunosuppression","Immunodeficiency","Severe acute febrile illness with or without fever, or acute illness of any severity with or without fever, that may impair the ability of the individual to participate in the vaccination process or may interfere with the immune response to the vaccine"]},"trials":[],"_chembl":null,"aliases":[],"company":"Pfizer Inc.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=rsvpref-mdv","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:51:58.528230+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:52:05.291590+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:51:58.550096+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rsvpref-mdv","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:52:06.130885+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Androgen Receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:52:06.781456+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1082407/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:52:06.661143+00:00"}},"allNames":"rsvpref mdv","offLabel":[],"timeline":[],"_dailymed":null,"aiSummary":"RSVpreF MDV, developed by Pfizer Inc., is a marketed drug for preventing RSV lower respiratory tract disease in high-risk neonates. It is a monoclonal antibody, offering a novel approach to RSV prevention. The drug's key indication is a significant clinical differentiation in the market. RSVpreF MDV's commercial significance lies in its potential to reduce RSV-related hospitalizations and complications. Currently, there are no pipeline developments mentioned for this drug. As a marketed product, it has already demonstrated its efficacy and safety profile. Overall, RSVpreF MDV is a valuable addition to Pfizer's portfolio, addressing a critical unmet need in neonatal care.","brandName":"RSVpreF MDV","ecosystem":[],"isGeneric":true,"mechanism":{"target":"RSV F protein","novelty":"Best-in-class","modality":"Monoclonal antibody","drugClass":"Monoclonal antibody","explanation":"","oneSentence":"","technicalDetail":"RSVpreF MDV is a humanized monoclonal antibody that targets the RSV F protein, preventing viral attachment and entry into host cells. It has been shown to be safe and effective in clinical trials, with a favorable safety profile and significant reduction in RSV-related hospitalizations."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:28:53.637Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"annualCostUS":"Generic pricing varies by manufacturer","genericStatus":"Biologic — patent protected","peakSalesEstimate":"Not publicly reported"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=rsvpref-mdv","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rsvpref-mdv","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:52:08.761433+00:00","fieldsConflicting":1,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Paxlovid","company":"Pfizer","advantage":"Paxlovid is a combination of nirmatrelvir and ritonavir, which is effective against COVID-19 and has a similar mechanism of action to RSVpreF MDV, targeting viral replication.","genericName":"Nirmatrelvir/ritonavir"},{"name":"Lagevrio","company":"Merck","advantage":"Lagevrio is an antiviral medication that targets the COVID-19 virus, similar to RSVpreF MDV, and has shown effectiveness in reducing hospitalization and mortality rates.","genericName":"Molnupiravir"},{"name":"Xofluza","company":"Shionogi","advantage":"Xofluza is an antiviral medication that targets the influenza virus, but has a similar mechanism of action to RSVpreF MDV, and has shown effectiveness in reducing the duration and severity of influenza symptoms.","genericName":"Baloxavir marboxil"}],"genericName":"rsvpref-mdv","indications":{"approved":[{"name":"Prevention of RSV lower respiratory tract disease in neonates at high risk of RSV disease","regulator":"FDA"},{"name":"Prevention of RSV lower respiratory tract disease in infants and children at high risk of RSV disease","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06473519","phase":"PHASE3","title":"A Study to Assess Safety, Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2024-06-24","conditions":"Respiratory Syncytial Virus (RSV)","enrollment":453}],"_emaApprovals":[{"date":"","name":"RSVpreF MDV","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":true,"chemblId":"CHEMBL1082407","moleculeType":"Small molecule","molecularWeight":"464.44"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL1082407"},"formularyStatus":[],"_approvalHistory":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"approved","companyName":"Pfizer Inc.","companyId":"pfizer","modality":"Monoclonal antibody","firstApprovalDate":"","enrichmentLevel":3,"visitCount":3,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:52:08.761433+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}