Roche said that the data from four clinical studies showed that Actemra/RoActemra reduced the risk of death in patients with severe or critical Covid-19
EU to approve Roche’s Actemra/RoActemra for Covid-19. (Credit: F. Hoffmann-La Roche Ltd.)
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the expanded approval for Roche’s Actemra/RoActemra (tocilizumab), to include the treatment of Covid-19.
CHMP recommended the drug for the treatment of Covid-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or ventilation.
The European Commission (EC) is expected to make a final decision regarding the approval of Actemra/RoActemra shortly.
Actemra/RoActemra is an anti-IL-6 receptor (aIL-6R) therapy, being jointly developed by Roche and Chugai Pharmaceutical, under a co-development agreement.
The drug has been approved in more than 110 countries for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA).
It was also approved for paediatric juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA) and CAR-T cell-induced cytokine release syndrome (CRS) indications.
Roche chief medical officer and global product development head Levi Garraway said: “As Covid-19 cases in Europe rise and with pressure on hospitals likely to increase, the need for effective treatments for those suffering most severely with Covid-19 could intensify.
“We are proud that the CHMP has recognised the potential of Actemra/RoActemra as we continue our efforts to bring treatment options to those most in need.”
CHMP commenced an accelerated evaluation of Actemra/RoActemra, in August this year, which is reserved for medicines with potential public health benefit.
The assessment considered results from Roche’s Phase 3 COVACTA, EMPACTA and REMDACTA trials, and the University of Oxford’s RECOVERY study, in more than 5,500 patients with severe Covid-19.
Evidence from the four clinical studies showed that Actemra/RoActemra reduced the risk of death in patients with severe or critical Covid-19.
The drug has been granted provisional approval in Australia, emergency use authorisation in the US and Ghana, and was endorsed by World Health Organization (WHO) to treat Covid-19.
According to a WHO report, interleukin 6 receptor blockers, such as Actemra/RoActemra are expected to show effectiveness in managing patients infected with new Omicron variant, claimed Roche.
In a separate development, Roche has completed the previously announced repurchase of its shares worth $20.7bn that had been held by Novartis.