Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 104 |
| INN | Nirsevimab |
| Status | Approved |
| Drug code(s) | MEDI8897, SP0232 |
| Brand name | Beyfortus |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | RSV |
| Indications of clinical studies | Respiratory syncytial virus |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 15, 2014 |
| Start of Phase 2 | November 15, 2016 |
| Start of Phase 3 | July 23, 2019 |
| Date BLA/NDA submitted to FDA | September 26, 2022 |
| Year of first approval (global) | 2022 |
| Date of first US approval | July 17, 2023 |
| INN, US product name | Nirsevimab, nirsevimab-alip |
| US or EU approved indications | EU: Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. US: Prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. |
| Company | AstraZeneca |
| Licensee/Partner | Sanofi, AIMM Therapeutics, Swedish Orphan Biovitrum |
| Comments about company or candidate | BLA submission announced on Jan 5, 2023; PDUFA date is in Q3 2023. November 4, 2022 press release. 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. estimates US submission in H2 2022 (Fast Track Designation, Breakthrough Therapy Designation) February 17, 2022 I 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. Nirsevimab is being developed by AstraZeneca in collaboration with Sanofi. June 2021: Nirsevimab MEDLEY Phase II/III trial demonstrated favourable safety and tolerability profile in infants at high risk of RSV MELODY (NCT05238974), MEDLEY and the Phase IIb trial will form the basis of AstraZeneca’s regulatory submissions planned for 2022. Nirsevimab has been granted breakthrough designation by three major regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; and access granted to the European Medicines Agency PRIority MEdicines (PRIME) scheme. The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) Designation to nirsevimab, an extended half-life monoclonal antibody (mAb) being investigated as a passive immunisation for the prevention of lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in all infants in their first RSV season, from birth and up to 12 months of age; and children with chronic lung disease or with haemodynamically significant congenital heart disease in their second RSV season, up to 24 months of age. NEJM article published July 30, 2020: A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants. (Funded by AstraZeneca and Sanofi Pasteur; ClinicalTrials.gov number, NCT02878330) NCT03979313 Phase 3 study started Jul 23 2019. NCT03959488 Phase 2/3 study not yet recruiting as of Jul 6, 2019. Listed as Phase 2 on MedImmune website accessed Feb 6, 2019. Feb 2019: EMA granted PRIME eligibility to MEDI8897 and FDA grants Breakthrough Therapy Designation for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV. Sanofi expects a proof of concept data read out for SP0232 for the treatment of RSV prophylaxis in the second half of 2018. Agreement with Sanofi announced in March 2017. Fast track designation announced in April 2015; NCT02290340 Phase 1/2 started in Jan 2015. In March 2017, AstraZeneca and Sanofi Pasteur announced an agreement to develop and commercialise MEDI8897 jointly. In November 2018, AstraZeneca announced Swedish Orphan Biovitrum AB (publ) (Sobi) has the right to participate in payments that may be received from the US profits or losses for MEDI8897. |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
Extended half-life (YTE; mAb-M252Y, S254T, T256E); target is F1 and F2 subunits of the RSV fusion (F) protein.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |