U.S. FDA grants priority review to Roche ’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults

If approved,Actemra/RoActemra would be the first U.S. FDA-approvedimmunomodulator for the treatment of COVID-19 inhospitalised patientsSince the beginning of the pandemic, more than one million peoplehospitalised with COVID-19 have been treated withActemra/RoActemra worldwide1Actemra/RoActemra is approved for the treatment of COVID-19 in many territories including the European UnionRoche has established a comprehensive access approach to improve availability ofActemra/RoActemra around the worldBasel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®/RoActemra® (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechani cal ventilation, or extracorporeal membrane oxygenation. A decision on U.S. FDA approval is expected in the second half of this year.“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Devel opment, Roche. “More than one million people with severe or critical COVID-19 have already been treated with Actemra...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news