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Palivizumab · 2 trials · 2 indications
An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).
| Arm | Type | Description |
|---|---|---|
| Children at High Risk of severe RSV Infection | EXPERIMENTAL | A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled. |
| Palivizumab | EXPERIMENTAL | 15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of severe respiratory syncytial virus (RSV) during the RSV season. |
| Name | Type | Description |
|---|---|---|
| Palivizumab | DRUG | Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV. |
Inclusion Criteria: Infants at high risk of severe RSV infection defined as fulfilling at least one of the following: * Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment * Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (BPD...
Palivizumab is used for the prevention of Respiratory Syncytial Virus (RSV) infection in children at high risk of severe disease. It is being developed for Respiratory Syncytial Virus Infection and Respiratory Syncytial Virus (RSV) in pediatric populations.
Palivizumab is developed by AbbVie Inc., which trades under the ticker ABBV. The company is conducting clinical studies of the drug in pediatric populations at risk for severe RSV infection.
Palivizumab is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are completed, and the drug remains under development for RSV prevention.
Palivizumab has completed two Phase 3 trials: NCT01466062 in Japanese newborns, infants, and young children with immunocompromised conditions, and NCT02968173 in children at high risk of severe RSV infection in Russia and Belarus. Both trials are completed.
Palivizumab is a small molecule that targets the RSV fusion protein, preventing the virus from entering host cells. It is designed to neutralize Respiratory Syncytial Virus and reduce the risk of severe lower respiratory tract disease.
Palivizumab is the generic name for the drug marketed as Synagis. It is a monoclonal antibody used to prevent RSV disease in high-risk children. AbbVie is developing it for RSV prevention in pediatric populations.