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 a monoclonal antibody used for RSV immunization, specifically to prevent hospitalizations due to respiratory syncytial virus (RSV) infection in healthy term and preterm infants during their first year of life. It is administered as a single intramuscular dose.
Nirsevimab is developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker SNY. The drug is currently in Phase 3 clinical development for RSV immunization.
Nirsevimab is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed, evaluating its efficacy in preventing RSV-related hospitalizations in infants.
Nirsevimab has one completed Phase 3 trial, identified as NCT05437510. This study enrolled 8,057 participants and evaluated a single intramuscular dose of Nirsevimab for preventing hospitalizations due to RSV infection in healthy term and preterm infants during their first year of life.
Nirsevimab is a monoclonal antibody, not a vaccine. It is designed to provide passive immunization against respiratory syncytial virus (RSV) in infants, helping to prevent severe RSV infection that could lead to hospitalization.
Nirsevimab is a monoclonal antibody that targets the respiratory syncytial virus (RSV). It works by binding to the virus to neutralize it, thereby preventing RSV infection and reducing the risk of hospitalization in infants during their first year of life.