Outside of the European Union, Actemra/RoActemra has been provisionally approved in Australia, authorised for emergency use in the United States and Ghana, and recommended by the World Health Organization (WHO) for the treatment of COVID-19.
These include the Roche-led phase III COVACTA, EMPACTA and REMDACTA trials, and the University of Oxford’s Randomised Evaluation of COVID-19 Therapy (RECOVERY) study, which was supported by Roche. The decision from the European Commission follows an accelerated assessment by the EMA’s CHMP, which reviewed results from four studies of Actemra/RoActemra in over 5,500 patients with severe or critical COVID-19.
Together with vaccines, other treatments and testing, Actemra/RoActemra forms an important piece of the care puzzle as we confront new challenges of the pandemic in Europe and around the world.” “The totality of evidence shows that Actemra/RoActemra can benefit those suffering with severe COVID-19. “Actemra/RoActemra is the second Roche medicine to have received rapid European Commission approval in COVID-19 in recent weeks,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. 1 This decision comes just hours after the recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), reflecting the urgent need for Actemra/RoActemra as a potential treatment option during the COVID-19 public health emergency.
Approval based on results from four phase III studies in over 5,500 patients.EMA’s CHMP recommended the approval yesterday.
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