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FDA accepts sBLA for Actemra and grants priority review in hospitalised COVID-19 patients

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Published:5th Apr 2022

Genentech/Roche announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

A decision on FDA approval is expected in the second half of this year.

The sBLA submission is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. Altogether, the results of these four studies (EMPACTA, COVACTA, REMDACTA and RECOVERY) suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. One of these studies, EMPACTA, was the first global, Phase III study to focus on patients from underrepresented racial and ethnic groups. There have been no new safety signals identified for Actemra in these studies. The most common adverse reactions seen (incidence at least 3%) are constipation, anxiety, diarrhea, insomnia, hypertension and nausea.

Condition: Coronavirus/Pneumonia
Type: drug

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