Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as motavizumab (MEDI-524), Medi-524, Rezield, MEDI-557
Motavizumab · 8 trials · 7 indications
RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
Number of participants reporting one or more AEs
Number of participants reporting one or more AEs considered related to study drug by the investigator
Number of participants reporting one or more SAEs
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
The occurrence of AEs and SAEs
Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| palivizumab | ACTIVE_COMPARATOR | 15 mg/kg administered intramuscularly for 5 monthly doses |
| motavizumab (MEDI-524) | EXPERIMENTAL | 15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses |
| Motavizumab followed by Palivizumab | EXPERIMENTAL | 2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Palivizumab followed by motavizumab | EXPERIMENTAL | 2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Motavizumab control | EXPERIMENTAL | 5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Motavizumab | EXPERIMENTAL | Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. |
| Pailvizumab | ACTIVE_COMPARATOR | Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| MEDI-557 low-dose | ACTIVE_COMPARATOR | - |
| MEDI-557 high-dose | ACTIVE_COMPARATOR | - |
| motavizumab (MEDI-524) 15 mg/kg | EXPERIMENTAL | A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| palivizumab 15 mg/kg | ACTIVE_COMPARATOR | A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. |
| Motavizumab, 3 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0 |
| Motavizumab, 15 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0 |
| Motavizumab, 30 mg/kg as a single intravenous dose | EXPERIMENTAL | Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 |
| Placebo, as a single intravenous dose | PLACEBO_COMPARATOR | Placebo, as a single intravenous dose administered on Day 0 |
| 1 | ACTIVE_COMPARATOR | MEDI-524 |
| 2 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 3 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 4 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| 5 | EXPERIMENTAL | MEDI-524 (Numax-TM) |
| Name | Type | Description |
|---|---|---|
| motavizumab (MEDI-524) | BIOLOGICAL | Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| palivizumab | BIOLOGICAL | Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| Motavizumab, palivizumab | BIOLOGICAL | Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl. |
| Palivizumab, motavizumab | BIOLOGICAL | Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine. |
| Motavizumab | BIOLOGICAL | Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl. |
| Placebo | DRUG | Placebo |
| MEDI-557 | DRUG | MEDI-557 low-dose |
| palivizumab 15 mg/kg | BIOLOGICAL | Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections. |
| Medi-524 | BIOLOGICAL | IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals |
| MEDI-524 (Numax-TM) | BIOLOGICAL | Grp.1: 3 mg/kg IV (single dose) |
Inclusion Criteria: * 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) wit...
Motavizumab is a monoclonal antibody developed for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk children. It has also been studied for RSV prophylaxis in children with hemodynamically significant congenital heart disease and for sequential administration with palivizumab within the same RSV season.
Motavizumab is developed by AstraZeneca PLC, which trades under the ticker AZN. The drug was studied under the designation MEDI-524 across its clinical program.
Motavizumab is an investigational monoclonal antibody that has been studied in Phase 1, Phase 2, and Phase 3 clinical trials. Its listed development phase is Phase 2, and it is not described as approved. All of its registered trials have been completed.
Motavizumab has been evaluated in completed trials including NCT00129766, a Phase 3 RSV prophylaxis study in high-risk children with 6,635 participants, NCT00538785, a Phase 2 study in children with hemodynamically significant congenital heart disease, NCT00316264, a Phase 2 sequential study with palivizumab, and NCT00192504, a Phase 1 safety study.
No. Motavizumab and palivizumab are distinct monoclonal antibodies, although both target respiratory syncytial virus. Motavizumab is also known as MEDI-524. One trial, NCT00316264, studied the two antibodies administered sequentially in the same RSV season rather than as the same product.