Nirsevimab

Therapeutic Nirsevimab antibody from the original Beyfortus® commercial drug.

Reference Standard as Aliquots

Beyfortus®
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Product Information

Here you will find the product information for the reference product.

Beyfortus® / Nirsevimab Reference Product

Drug nameBeyfortus®
INNNirsevimab
API typeNirsevimab 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 releaseAstraZeneca 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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