Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nirsevimab · 4 trials · 4 indications
An AE was development of any untoward medical occurrence in a participant or clinical study participant administered medicinal product and which did not necessarily have causal relationship with this treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab through 360 days post second dose. An SAE was any AE that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or birth defect or was an important medical event that might jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AESIs were based on assessment by investigators following the administration of nirsevimab. An NOCD was a newly diagnosed medical condition of chronic, ongoing nature post administration of study drug.
Incidence of all medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab and within 360 days post dose. A TESAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant. AESIs were defined as AEs of immediate (type I) hypersensitivity (including anaphylaxis), thrombocytopenia, and immune complex disease following the administration of nirsevimab based on investigator assessment and Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) codes. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature post administration of treatment.
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
Cmax for nirsevimab was directly calculated from the individual concentration-time curve.
Tmax for nirsevimab was directly calculated from the individual concentration-time curve.
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab was calculated by linear up/log down trapezoidal summation.
| Arm | Type | Description |
|---|---|---|
| MEDI8897 | EXPERIMENTAL | Anti-RSV monoclonal antibody |
| Nirsevimab | EXPERIMENTAL | Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo. |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo. |
| Name | Type | Description |
|---|---|---|
| Nirsevimab | DRUG | Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose. |
| Placebo | DRUG | Commercially available 0.9% (w/v) saline (sterile for human use) fixed IM dose of 0.5 mL (if weight \<5 kg) or 1.0 mL (if weight \>=5 kg) |
Inclusion Criteria: 1. Written informed consent and any locally required authorization obtained from the participant's parent(s)/legally authorized representative(s) before performing any protocol-related procedures, including screening evaluations 2. Japanese infants of ≤12 months of age eligible ...
Nirsevimab is an investigational drug being studied for the prevention of Respiratory Syncytial Virus (RSV) infections, including lower respiratory tract infections. It is being evaluated in clinical trials involving infants, children, and adults, with studies conducted in various countries including China, Japan, and the United States.
Nirsevimab is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and efficacy of Nirsevimab in different patient populations.
Nirsevimab is in Phase 3 clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials, including studies in healthy Chinese adults, immunocompromised children, and healthy preterm and term infants in China. The drug is investigational and not yet approved for commercial use.
Nirsevimab has been studied in several completed clinical trials, including NCT04484935 (Phase 2 in immunocompromised children with RSV), NCT04840849 (Phase 1 in healthy Chinese adults), NCT05110261 (Phase 3 in healthy preterm and term infants in China), and NCT06042049 (Phase 3 in Japanese participants).
Nirsevimab is a small molecule therapeutic agent. It is being studied for its ability to prevent RSV infections by targeting the respiratory syncytial virus. The drug is administered to individuals at risk of RSV infection, including infants and immunocompromised patients, to provide protection against the virus.
Nirsevimab is a distinct investigational drug developed by AstraZeneca. It is not the same as other RSV treatments currently on the market. Nirsevimab is being evaluated in clinical trials for its safety and efficacy in preventing RSV infections in various populations, including infants and adults.