Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
palivizumab · 1 trial · 4 indications
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.
Number of subjects experiencing an RSV hospitalization
| Arm | Type | Description |
|---|---|---|
| palivizumab | EXPERIMENTAL | palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections |
| Name | Type | Description |
|---|---|---|
| palivizumab | BIOLOGICAL | palivizumab 15 mg/kg intramuscularly |
Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled into the study: 1. Infants at high risk of severe RSV infection defined as fulfilling at least one of the following: * Infants born at less than or equal to 35 weeks gestational age AND are less than or equal t...
Palivizumab is a monoclonal antibody used for the prevention of severe Respiratory Syncytial Virus (RSV) infection. It is being studied in children at high risk, including those with premature birth, bronchopulmonary dysplasia, and congenital heart disease.
Palivizumab is being developed by Abbott Laboratories, traded under the ticker ABT. The company is conducting clinical research on this monoclonal antibody for the prevention of RSV infection.
Palivizumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug is not currently in active trials.
Palivizumab has one completed clinical trial, NCT01006629, titled 'Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children.' This Phase 2 study enrolled 100 participants in Russia and was not randomized or double-blinded.
Palivizumab is a monoclonal antibody that targets the RSV fusion protein, neutralizing the virus and preventing it from infecting cells. This mechanism helps reduce the risk of severe lower respiratory tract disease caused by RSV in high-risk children.