FDA AUTHORIZES ACTEMRA, FOR EMERGENCY USE IN THE TREATMENT OF COVID-19

Edited by, JASPER VICTORIA

FDA issued an Emergency Use Authorization (EUA) for the drug Actemra (tocilizumab), a monoclonal antibody, a product of the Genentech inc. in the treatment of covid-19 for adult and paediatric hospitalised patients. It is not meant for the use in outpatients and in patients below two years of age. It should be given only to those patients who are in need of oxygenation or ventilation and are being administered systemic corticosteroids.

The patients' risk for death, duration of hospitalization and need for ventilators were reduced during the 28 days when they were given Actemra along with the usual covid management therapy such as the corticosteroids etc., during the clinical trials in the hospitalized covid patients.

Actemra is already in use for inflammatory conditions such as the rheumatoid arthritis etc., during the treatment of which, it is given as intravenous infusion. 

The monoclonal antibody, Actemra does not directly attack the SARS-CoV-2, it rather elicits its action by blocking the interleukin-6 receptor and hence reduce the inflammation associated with the COVID-19 infection.

The FDA has not approved Actemra as a treatment for covid-19, rather, it is only authorized to be used in case of emergency in hospitalized covid-19 patients.

Actemra was authorized for emergency use in hospitalized covid patients based on four clinical trials such as RECOVERY (Randomized Evaluation of Covid-19 Therapy) and COVACTA, EMPACTA, REMDACTA , of which the RECOVERY & EMPACTA evinced the potential benefits of actemra to be used in emergency situations.

2022 patients were given Actemra along with the usual therapy and 2094 patients were given only the usual therapy without the inclusion of Actemra, amongst the 4116 hospitalized covid-19 patients for 28 days during the RECOVERY trial. The death probability was 3.8% higher for those patients who were given only the usual therapy without Actemra, than those that recieved Actemra along with the routine treatment. The Actemra administered patients were ready for discharge in about 19 days, whereas it took more than 28 days for those not given Actemra.

The need for ventilators or death within 28 days were evaluated in the EMPACTA trial, which was conducted with 389 hospitalized covid patients, amongst which 249 patients were provided Actemra. The risk of death or need for ventilation were 7.3% higher in those patients who were not administered Actemra.

Constipation, nausea, diarrhea, anxiety, hypertension and insomnia were the commonly observed side-effects during the clinical trials.

The FDA advises the HCPs to be aware of the instructions regarding the dosing, administration, side-effects, interactions of Actemra to be used safely and efficiently during the treatment of COVID-19.