Nirsevimab

Nirsevimab, sold under the brand name Beyfortus, is a human recombinant monoclonal antibody with activity against respiratory syncytial virus, or RSV for infants.[1][2] It is under development by AstraZeneca and Sanofi.[1][2] Nirsevimab is designed to bind to the fusion protein on the surface of the RSV virus.[3][4]

Nirsevimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetF protein of RSV
Clinical data
Other namesMED-18897, MEDI8897
Routes of
administration		Intramuscular
ATC code
  • None
Identifiers
CAS Number
PubChem SID
DrugBank
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6494H10060N1708O2050S46
Molar mass146336.58 g·mol−1

The most common side effects reported for nirsevimab were rash, pyrexia (fever) and injection site reactions (such as redness, swelling and pain where the injection is given).[5]

Mechanism of action

Nirsevimab binds to the prefusion conformation of the RSV fusion protein, i.e. it binds to the site at which the virus would attach to a cell; effectively rendering it useless. It has a modified Fc region, extending the half-life of the drug in order for it to last the whole RSV season.[3]

Clinical efficacy

The pivotal MELODY study is an ongoing, randomized, double-blind, placebo-controlled to evaluate the safety and efficacy of nirsevimab in late preterm and term infants. Initial results have been promising, with nirsevimab reducing LRTI (lower respiratory tract infections) by 74.5% compared to placebo in infants born at term or late preterm.[6]

Adverse effects

No major hypersensitivity reactions have been reported, and adverse events of grade 3 or higher were only reported in 8% (77 of 968) of participants in clinical trial NCT02878330.[7][3]

History

The opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is based on data from two randomized, double-blind, placebo-controlled multicenter clinical trials that investigated the efficacy and safety of nirsevimab in healthy preterm (premature) and full-term infants entering their first respiratory syncytial virus (RSV) season.[5] These studies demonstrated that nirsevimab prevents lower respiratory tract infection caused by RSV requiring medical attention (such as bronchiolitis and pneumonia) in term and preterm infants during their first RSV season.[5]

The safety of nirsevimab was also evaluated in a phase II/III, randomized, double‑blind, multicenter trial in infants who were born five or more weeks prematurely (less than 35 weeks gestation) at higher risk for severe RSV disease and infants with chronic lung disease of prematurity (i.e. long-term respiratory problems faced by babies born prematurely) or congenital heart disease.[5] The results of this study showed that nirsevimab had a similar safety profile compared to palivizumab (Synagis).[5]

Society and culture

On 15 September 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Beyfortus, intended for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in newborns and infants.[8][5] Beyfortus was reviewed under EMA's accelerated assessment program.[8] The applicant for this medicinal product is AstraZeneca AB.[8]

Research

Nirsevimab is being investigated as an experimental vaccine against respiratory syncytial virus, RSV, in the general infant population.[1][2]

Ongoing trials for nirsevimab are:

References
  1. "Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial" (Press release). Online: Sanofi. 26 April 2021. Archived from the original on 27 December 2021. Retrieved 27 December 2021.
  2. "Nirsevimab MELODY Phase III trial met primary endpoint of reducing RSV lower respiratory tract infections in healthy infants" (Press release). Online: AstraZeneca. 26 April 2021. Archived from the original on 26 December 2021. Retrieved 27 December 2021.
  3. Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, et al. (Nirsevimab Study Group) (July 2020). "Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants". The New England Journal of Medicine. 383 (5): 415–425. doi:10.1056/NEJMoa1913556. PMID 32726528. S2CID 220876651.
  4. Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, et al. (March 2022). "Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants". The New England Journal of Medicine. 386 (9): 837–846. doi:10.1056/NEJMoa2110275. PMID 35235726. S2CID 247220023.
  5. "New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection". European Medicines Agency (EMA) (Press release). 16 September 2022. Archived from the original on 19 September 2022. Retrieved 18 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. Zacks Equity Research (March 25, 2022). "Pfizer's (PFE) RSV Jab Gets Another Breakthrough Therapy Tag". Nasdaq. Archived from the original on April 8, 2022. Retrieved April 8, 2022.
  7. Clinical trial number NCT02878330 at ClinicalTrials.gov
  8. "Beyfortus: Pending EC decision". European Medicines Agency (EMA). 15 September 2022. Archived from the original on 19 September 2022. Retrieved 18 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.