Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nirsevimab · 1 trial · 2 indications
LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths per minute (/min); 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection.
| Arm | Type | Description |
|---|---|---|
| Nirsevimab | EXPERIMENTAL | 1 intramuscular injection at Day 01 |
| No preventive intervention for RSV | NO_INTERVENTION | No intervention |
| Name | Type | Description |
|---|---|---|
| Nirsevimab | BIOLOGICAL | Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular |
Inclusion Criteria: * Born at ≥ 29 weeks gestational age and aged 0 to 12 months (calendar age), who entered their first RSV season on the day of inclusion in the study (D01) * Informed consent form was signed and dated by the parent(s) or other LAR(s) (and by an independent witness if required by ...
Nirsevimab is used for RSV immunization, specifically to prevent hospitalizations caused by respiratory syncytial virus infection in healthy term and preterm infants during their first year of life. It is a monoclonal antibody given as a single intramuscular dose and is being developed by Sanofi.
Nirsevimab is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the company listed as the developer of the asset in its clinical program for RSV immunization in infants.
Nirsevimab is in Phase 3 clinical development. It is an investigational monoclonal antibody and is not described as approved. Its Phase 3 program has been completed, with one completed trial and no active trials currently listed.
Nirsevimab has been studied in the Phase 3 trial NCT05437510, titled a study of a single intramuscular dose of nirsevimab in the prevention of hospitalizations due to respiratory syncytial virus infection in healthy term and preterm infants during the first year of life. That trial is completed and enrolled 8,057 participants across France, Germany, and the United Kingdom.
The Phase 3 trial NCT05437510 was a randomized study with a no-treatment control and enrolled 8,057 healthy infant volunteers, including term and preterm infants, with ages starting at 0 days and both sexes eligible. It was not double blinded and was not biomarker selected.