JP-2022531205-A5 -

Dates

Publication Date

20230511

Application Date

20200430

Description

Further Embodiments of the Invention 1. A method for treating or preventing RSV infection in patients in need thereof, To determine the age of the aforementioned patient; For the aforementioned patient in the second year of life, administer a fixed dose of 200 milligrams (mg) of anti-RSV monoclonal antibody or a composition containing its antigen-binding fragment; The procedure includes determining the patient's weight in the case of a patient who is one year old; and administering a composition containing a fixed dose of 100 mg of anti-RSV monoclonal antibody or its antigen-binding fragment to a patient who has a weight of at least 5 kilograms (kg), The anti-RSV monoclonal antibody or its antigen-binding fragment is characterized in that it has an IC50 of 5.0 ng/ml or less in a neutralization assay for RSV A, or an IC50 of 3.0 ng/ml or less in a neutralization assay for RSV B9320, or both. 2. A method for treating or preventing RSV infection in a patient in need thereof, comprising administering a fixed dose of 200 milligrams (mg) of anti-RSV monoclonal antibody or its antigen-binding fragment to a patient having a body weight of at least 5 kilograms (kg), wherein the anti-RSV monoclonal antibody or its antigen-binding fragment has an IC50 of 5.0 ng/ml or less in an RSV A neutralization assay, or an IC50 of 3.0 ng/ml or less in an RSV B9320 neutralization assay, or both. 3. A method for treating or preventing RSV infection in patients who require it, Determining the patient's weight, Administering a fixed dose of 200 milligrams (mg) of anti-RSV monoclonal antibody or its antigen-binding fragment to a patient having a body weight of at least 5 kilograms (kg), wherein the anti-RSV monoclonal antibody or its antigen-binding fragment has an IC50 of 5.0 ng/ml or less in an RSV A neutralization assay, or an IC50 of 3.0 ng/ml or less in an RSV B9320 neutralization assay, or both: A method comprising administering a fixed dose of 100 mg of an anti-RSV monoclonal antibody or its antigen-binding fragment to a patient weighing up to 5 kg, wherein the anti-RSV monoclonal antibody or its antigen-binding fragment has an IC50 of 5.0 ng/ml or less in an RSV A neutralization assay, or an IC50 of 3.0 ng/ml or less in an RSV B9320 neutralization assay, or both. 4. A method for treating or preventing RSV infection in patients who require it, A method comprising: determining the age of the patient; and administering a fixed dose of 200 milligrams (mg) of anti-RSV monoclonal antibody or its antigen-binding fragment to a patient aged 3 months or older, wherein the anti-RSV monoclonal antibody or its antigen-binding fragment has an IC50 of 5.0 ng/ml or less in an RSV A neutralization assay, or an IC50 of 3.0 ng/ml or less in an RSV B9320 neutralization assay, or both. 5. A method for treating or preventing RSV infection in patients who require it, Determining the patient's age; Administer a fixed dose of 200 milligrams (mg) of anti-RSV monoclonal antibody or its antigen-binding fragment to patients aged 3 months or older; This includes administering a fixed dose of 100 mg of anti-RSV monoclonal antibody or its antigen-binding fragment to patients up to 3 months of age. The anti-RSV monoclonal antibody or its antigen-binding fragment is characterized in that it has an IC50 of 5.0 ng/ml or less in a neutralization assay for RSV A, or an IC50 of 3.0 ng/ml or less in a neutralization assay for RSV B9320, or both. 6. A method for treating or preventing RSV infection in patients who require it, Determining the patient's age; Administer a fixed dose of 200 milligrams (mg) of anti-RSV monoclonal antibody or its antigen-binding fragment to patients 6 months of age or older; This includes administering a fixed dose of 100 mg of anti-RSV monoclonal antibody or its antigen-binding fragment to patients up to 6 months of age. The anti-RSV monoclonal antibody or its antigen-binding fragment is characterized in that it has an IC50 of 5.0 ng/ml or less in a neutralization assay for RSV A, or an IC50 of 3.0 ng/ml or less in a neutralization assay for RSV B9320, or both. 7. A method for treating or preventing RSV infection in patients who require it, To determine whether the patient has experienced the first or second RSV epidemic; For patients experiencing the aforementioned second RSV season, administer a composition containing a fixed dose of 200 milligrams (mg) of anti-RSV monoclonal antibody or its antigen-binding fragment; The procedure includes determining the weight of a patient who has experienced the aforementioned initial RSV epidemic; and administering a composition containing a fixed dose of 100 mg of anti-RSV monoclonal antibody or its antigen-binding fragment to a patient having a weight of at least 5 kilograms (kg). The anti-RSV monoclonal antibody or its antigen-binding fragment is characterized in that it has an IC50 of 5.0 ng/ml or less in a neutralization assay for RSV A, or an IC50 of 3.0 ng/ml or less in a neutralization assay