The US FDA has accepted the company’s supplemental Biologics License Application (sBLA) for tocilizumab and is expected to announce its decision in the second half of this year
Roche Diagnostics administration and R&D buildings. (Credit: F. Hoffmann-La Roche Ltd)
The US Food and Drug Administration (FDA) has granted priority review for Roche’s Actemra/RoActemra (tocilizumab) to treat Covid-19 in hospitalised adults.
The therapy was indicated for treating hospitalised Covid-19 patients who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.
The US agency has accepted the company’s supplemental Biologics License Application (sBLA) for tocilizumab and is expected to announce its decision in the second half of this year.
If approved, Actemra/RoActemra will become the first US FDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients, said Roche.
In June last year, Actemra/RoActemra received emergency use authorisation (EUA) from the US FDA and is currently approved in 116 countries worldwide in various indications.
The company’s sBLA submission is based on results from four randomised, controlled studies of Actemra/RoActemra in more than 5,500 hospitalised patients.
In the four trials, EMPACTA, COVACTA, REMDACTA, and RECOVERY, the therapy has improved outcomes in patients receiving corticosteroids and requiring supplemental oxygen.
Roche global product development head and chief medical officer Levi Garraway said: “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.
“More than one million people with severe or critical Covid-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”
In a separate development, Roche has unveiled new data showing clinical benefit of Ocrevus (ocrelizumab) on disease progression and cognitive outcomes related to primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS).
Ocrevus is a humanised monoclonal antibody that targets CD20-positive B cells, a specific type of immune cells believed to contribute to myelin and axonal damage.
Administered by intravenous infusion every six months, the initial doses of Ocrevus are given as two 300mg infusions, two weeks apart, and subsequent doses as single 600mg infusions.
In the one-year interim analysis of the CONSONANCE Phase 3b trial, treatment using Ocrevus prevented the disease progression in a majority of patients.
After one year, 75% of SPMS and PPMS patients treated with Ocrevus achieved no evidence of disease progression, in the study.
Ocrevus is currently approved in 100 countries, including in North America, South America, the Middle East, and Eastern Europe, along with Australia, Switzerland, the UK and the EU.