Nirsevimab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Nirsevimab
- beyfortus
- Beyfortus
- beyfortus
- Beyfortus
- med 18897
- MED-18897
- medi8897
- Medi8897
- MEDI8897
- MEDI8897 10 mg
- MEDI8897 25 mg
- MEDI8897 50 mg
- MEDI8897 Intramuscular
- MEDI8897 Intravenous
- nirsevimab
- Nirsevimab
- nirsevimab [INN]
- NIRSEVIMAB [JAN]
- Nirsevimab [MI]
- NIRSEVIMAB [USAN]
- Nirsevimab [WHO-DD]
- nirsevimab alip
- Nirsevimab alip [WHO-DD]
- nirsevimab alip who dd
- nirsevimab inn
- nirsevimab jan
- nirsevimab mi
And 3 more, listed on the interactive page.
- ATC classification codes
- J06BD08
Sources for recorded values
- CAS registry numbers
- 1989556-22-0
- ChEMBL ID
- CHEMBL4297575
- FDA ingredient codes (UNII)
- VRN8S9CW5V
- 2642401
- 2642402
- Applicant
- ASTRAZENECA AB
- Approval date
- 17 Jul 2023
- Application number
- BLA761328
- Status
- Authorised
- Status date
- 31 Oct 2022
- Authorisation date
- 31 Oct 2022
- Approved indications
- Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i. Neonates and infants during their first RSV season.ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations. Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i. Neonates and infants during their first RSV season.ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations.
- Product number
- EMEA/H/C/005304
- Authorisation holder
- Sanofi Winthrop Industrie
- Priority medicines scheme
- Yes
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
European medicines record
- Patents
- 0
- Designations
- 3
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- -mab
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Fusion glycoprotein F0 inhibitor
- Action type
- Inhibitor
- Target
- Fusion glycoprotein F0
- Protein identifier
- Q89535
Open Targets mechanisms
- Mechanism
- Fusion glycoprotein F0 inhibitor
- Action type
- Inhibitor
- Target
- Fusion glycoprotein F0
- Condition
- Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Respiratory Syncytial Viruses
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001413
- Subject identifier
- D012136
- Condition
- Respiratory Syncytial Virus Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001413
- Subject identifier
- D018357
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009433
- Condition identifier
- EFO_1001413
- Condition identifier
- HP_0002783
- Condition identifier
- HP_0002783
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0000270
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0001577
- Highest recorded phase
- 4
Reported adverse events
- Event
- accelerated idioventricular rhythm
- Reports
- 1
- Reporting signal score
- 9.75473
- NCT02114268
- NCT02290340
- NCT02878330
- NCT03959488
- NCT03979313
- NCT04484935
- NCT06042049
- NCT05110261
- Dose
- 50 mg or 100 mg or 200 mg
- Route
- Intramuscular
- How often
- Once per RSV season or as specified
- Administer as an intramuscular injection
- Do not inject if solution is cloudy or discolored
- Use a different injection site for repeated injections
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Glycosylation sites (N)
- Sequence
- Asn-306$Asn-306''''
- Component
- Glycosylation sites (N)
- Sequence
- Asn-306$Asn-306''
- Component
- Disulfide bridges location
- Sequence
- 22-96$22''-96''$23'-88'$23'''-88'''$134'-194'$134'''-194'''$153-209$153''-209''$214'-229$214'''-229''$235-235''$238-238''$270-330$270''-330''$376-434$376''-434''
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSAAVGDRVTITCQASQDIVNYLNWYQQKPGKAPKLLIYVASNLETGVPSRFSGSGSGTDFSLTISSLQPEDVATYYCQQYDNLPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGSSVMVSCQASGGLLEDYIINWVRQAPGQGPEWMGGIIPVLGTVHYGPKFQGRVTITADESTDTAYMELSSLRSEDTAMYYCATETALVVSETYLPHYFDNWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 49281-574
- 49281-575
Related records
Trials (26)
- A Clinical Trial of SIBP-A16 Injection in Healthy Adults
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
- A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
- A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
- A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
- A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
- An Observational Study to Assess Nirsevimab Immunization Rates in Eligible Infants During Their First RSV Season in the Czechia
- Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)
- Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá
- Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
- Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
- Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children
- Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
- Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
- Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
- Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination.
- Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination
- Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants