EMA ISSUES ADVICE ON REGENERON'S ANTIBODY COCKTAIL (CASIRIVIMAB WITH IMDEVIMAB) FOR CERTAIN COVID-19 PATIENTS

- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic respiratory disease.
- BMI =85th percentile for their age and gender based on?CDC?growth charts,?https://www.cdc.gov/growthcharts/clinical_charts.htm,OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders (e.g., cerebral palsy), OR
- a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.
- Signs and symptoms of infusion related reactions may include?fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, fatigue and diaphoresis. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
Regeneron Contacts: | |
Media Relations Sarah Cornhill media@regeneron.com | Investor Relations Vesna Tosic investor@regeneron.com |
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