Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Baloxavir Marboxil · 6 trials · 1 indication
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability or incapacity, was a congenital anomaly or birth defect.
The virological transmission was determined based on Polymerase Chain Reaction Positive (PCR+) influenza test results. The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of the respective IP, irrespective of being symptomatic or asymptomatic. The adjusted incidence rates presented were estimated using a generalized estimating equations (GEE) approach.
Time to Clinical Improvement (TTCI) is defined as Time to Hospital Discharge OR Time to NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
| Arm | Type | Description |
|---|---|---|
| Baloxavir Marboxil | EXPERIMENTAL | Participants will receive a single oral dose of baloxavir marboxil on Day 1 based on body weight. |
| Oseltamivir | ACTIVE_COMPARATOR | Participants will receive oseltamivir twice a day for 5 days based on body weight. |
| Placebo | PLACEBO_COMPARATOR | Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication. |
| Name | Type | Description |
|---|---|---|
| Baloxavir Marboxil | DRUG | Baloxavir marboxil will be administered as oral suspension: 2 milligrams per kilograms (mg/kg) (if weight \< 20 kg), 40 mg (if weight ≥ 20 kg to \< 80 kg), or 80 mg (if weight ≥ 80 kg). |
| Oseltamivir | DRUG | Oseltamivir will be administered as oral capsule: 30 mg (if weight ≤15 kg), 45 mg (if weight \> 15 kg to ≥ 23 kg), 60 mg (if weight \> 23 kg to ≤ 40 kg) or 75 mg (if weight \> 40 kg), twice daily (BID) for 5 days. |
| Placebo | DRUG | IPs less than 12 years old will receive placebo oral suspension and those above 12 years will receive placebo tablets. HHCs of IPs will not receive study medication. |
Inclusion Criteria: * A participant who has a diagnosis of influenza virus infection and meets all the following conditions: * Fever ≥ 38°C (tympanic temperature) at screening * At least one of the respiratory symptoms of influenza virus infection * A rapid influenza diagnostic test (RIDT) or ...
Baloxavir Marboxil is an investigational small molecule being developed for the treatment of influenza. It is currently in Phase 3 clinical trials, which are evaluating its safety and efficacy in various patient populations, including pediatric and hospitalized patients with severe influenza.
Baloxavir Marboxil is a small molecule antiviral that targets the influenza virus. It works by inhibiting the cap-dependent endonuclease activity of the viral polymerase, which is essential for viral replication. This mechanism is distinct from neuraminidase inhibitors, which are the standard of care for influenza.
Baloxavir Marboxil is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting Phase 3 clinical trials to assess the drug's safety, pharmacokinetics, and efficacy in treating influenza across different age groups and severity levels.
Baloxavir Marboxil is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing and completed Phase 3 trials are designed to support a potential regulatory submission for the treatment of influenza.
Baloxavir Marboxil has been studied in several Phase 3 trials, including NCT03629184 in pediatric participants, NCT03653364 in infants under 1 year, NCT03684044 in hospitalized patients with severe influenza, and NCT03969212 to reduce onward transmission in households. These trials are completed.
Baloxavir Marboxil is the generic name for the drug marketed as Xofluza. It is an antiviral medication used to treat influenza. The drug is being developed by Roche and is currently in Phase 3 clinical trials for additional indications and patient populations.