Therapeutic Nirsevimab antibody from the original Beyfortus® commercial drug.
Evidentic’s analytical service includes a comprehensive array of methods to support the drug development process, including, for example, structure, aggregation, degree of isomerization and N-glycans identification of the active pharmaceutical ingredient (API).
Here you will find the product information for the reference product.
| Drug name | Beyfortus® |
| INN | Nirsevimab |
| API type | Nirsevimab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Immune sera and immunoglobulins, antiviral monoclonal antibodies |
| ATC code | J06BD08 |
| Target of antibody | RSV protein F |
| General function | |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Nirsevimab is a recombinant neutralising human IgG1ĸ long-acting monoclonal antibody to the prefusion conformation of the RSV F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half-life. Nirsevimab binds to a highly conserved epitope in antigenic site Ø on the prefusion protein with dissociation constants KD = 0.12 nM and KD = 1.22 nM for RSV subtype A and B strains, respectively. Nirsevimab inhibits the essential membrane fusion step in the viral entry process, neutralising the virus and blocking cell-to-cell fusion. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Antiviral activity The cell culture neutralisation activity of nirsevimab against RSV was measured in a dose-response model using cultured Hep-2 cells. Nirsevimab neutralised RSV A and RSV B isolates with median EC50 values of 3.2 ng/mL (range 0.48 to 15 ng/mL) and 2.9 ng/mL (range 0.3 to 59.7 ng/mL), respectively. The clinical RSV isolates (70 RSV A and 49 RSV B) were collected between 2003 and 2017 from subjects across the United States, Australia, Netherlands, Italy, China and Israel and encoded the most common RSV F sequence polymorphisms found among circulating strains. Nirsevimab demonstrated in vitro binding to immobilised human FcγRs (FcγRI, FcγRIIA, FcγRIIB, and FcγRIII) and equivalent neutralising activity compared to parental monoclonal antibodies, IG7 and IG7-TM (Fc region modified to reduce FcR binding and effector function). In a cotton rat model of RSV infection, IG7 and IG7-TM exhibited comparable dose-dependent reduction in RSV 7 replication in the lungs and nasal turbinates, strongly suggesting that protection from RSV infection is dependent on nirsevimab neutralisation activity rather than Fc-mediated effector function. Antiviral resistance In cell culture Escape variants were selected following three passages in cell culture of RSV A2 and B9320 strains in the presence of nirsevimab. Recombinant RSV A variants that showed reduced susceptibility to nirsevimab included those with identified substitutions N67I+N208Y (103-fold as compared to reference). Recombinant RSV B variants that showed reduced susceptibility to nirsevimab included those with identified substitutions N208D (>90,000-fold), N208S (>24,000-fold), K68N+N201S (>13,000-fold), or K68N+N208S (>90,000-fold). All resistance-associated substitutions identified among neutralisation escape variants were located in the nirsevimab binding site (amino acids 62-69 and 196-212) and were shown to reduce binding affinity to RSV F protein. In clinical trials In MELODY, MEDLEY and MUSIC, no subject with medically attended RSV lower respiratory tract infection (MA RSV LRTI) had an RSV isolate containing nirsevimab resistance-associated substitutions in any treatment group. In D5290C00003 (subjects who received a single dose of 50 mg nirsevimab irrespective of weight at time of dosing), 2 of 40 subjects in the nirsevimab group with MA RSV LRTI had an RSV isolate containing nirsevimab resistance-associated substitutions. No subjects in the placebo group had an RSV isolate containing nirsevimab resistance-associated substitution. Recombinant RSV B variants harbouring the identified I64T+K68E+I206M+Q209R (>447.1-fold) or N208S (>386.6-fold) F protein sequence variations in the nirsevimab binding site conferred reduced susceptibility to nirsevimab neutralisation. Nirsevimab retained activity against recombinant RSV harbouring palivizumab resistance-associated substitutions identified in molecular epidemiology studies and in neutralisation escape variants of palivizumab. It is possible that variants resistant to nirsevimab could have cross-resistance to other monoclonal antibodies targeting the F protein of RSV. |
| Original license holder | |
| Marketing authorisation numbers | EU/1/22/1689/001 50 mg, 1 single-use pre-filled syringe EU/1/22/1689/002 50 mg, 1 single-use pre-filled syringe with needles EU/1/22/1689/003 50 mg, 5 single-use pre-filled syringe EU/1/22/1689/004 100 mg, 1 single-use pre-filled syringe EU/1/22/1689/005 100 mg, 1 single-use pre-filled syringe with needles EU/1/22/1689/006 100 mg, 5 single-use pre-filled syringe |
| Marketing authorisation holder | Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France |
| Name of the manufacturer of the biological active substance | AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court Frederick, Maryland 21703 United States |
| Name and address of the manufacturer(s) responsible for batch release | AstraZeneca AB Karlebyhusentren, Astraallen 152 57 Södertälje Sweden |
| Max shelf life | 3 years Beyfortus may be kept at room temperature (20°C - 25°C) when protected from light for a maximum of 8 hours. After this time, the syringe must be discarded. |
| Storage conditions | 2°C – 8°C |
| List of excipients | L-histidine L-histidine hydrochloride L-arginine hydrochloride Sucrose Polysorbate 80 (E433) Water for injections |
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