FDA accepts sBLA for Actemra and grants priority review in hospitalised COVID-19 patients
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.
Related news and insights
Palisade Bio, Inc. announced the first patient has been dosed in its Phase III study evaluating LB 1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery.
bluebird bio, Inc. announced the FDA has approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.
Edwards Lifesciences Corporation announced the company's PASCAL Precision transcatheter valve repair system received CE Mark for the treatment of mitral and tricuspid regurgitation (MR and TR).