Overview:
The indication for use is for mild and moderate Covid-19 cases in adults and pediatric patients (12 years and older) with laboratory-confirmed infection.
Introduction:
The National Health Surveillance Agency (Anvisa) approved the authorization for the emergency use of the monoclonal antibodies casirivimab and imdevimab, administered together by intravenous infusion, in the treatment of Covid-19.
Indication and Warning
The drugs are indicated for mild and moderate cases of the disease in adults and pediatric patients (12 years and older) with laboratory-confirmed Sars-CoV-2 infection who are at high risk of progressing to severe forms of the disease. This includes patients 65 years of age or older or who have certain chronic medical conditions.
It is important to note that these antibodies do not prevent the disease.
Antibodies Administration
The antibodies will only be administered in a hospital environment. However, the Agency clarifies that the antibodies are not authorized for use in patients who are hospitalized due to Covid-19 or who require high-flow oxygen or mechanical ventilation for their treatment. According to clinical trial data, the antibodies have not demonstrated a benefit in hospitalized patients.
Possible side effects include anaphylaxis (acute allergic reaction), fever, chills, hives, itching, and flushing. According to Anvisa, the safety and efficacy of the antibodies are still being evaluated through ongoing studies.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.