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CHMP recommend approval for Roche’s COVID-19 therapy

According to clinical data, Roche’s new COVID-19 treatment Actemra/RoActemra lowered mortality risk in critically ill adult patients.

Roche has announced the Committee for Medicinal Products for Human Use (CHMP) has recommended extending the marketing authorisation for Roche’s COVID-19 therapy, Actemra/RoActemra (tocilizumab), to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

The CHMP began an accelerated analysis of the therapy in August 2021, reviewing data from four clinical trials and enrolling over 5,500 severe or critical COVID-19 patients. The clinical trial data revealed that Actemra/RoActemra lowered mortality risk in adults with severe or critical diseases.

“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,” shared Levi Garraway, Roche’s chief medical officer and head of global product development. “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.”

Data from phase 3 COVAVTA, EMPACTA and REMDACTA trials led by Roche and the company-supported RECOVERY trial by Oxford University in the UK were analysed by the committee. A final decision regarding the approval of Actemra/RoActemra is expected from the European Commission in the near future.

The therapy received an Emergency Use Authorisation (EUA) in the US and is also recommended by the World Health Organisation (WHO) to treat COVID-19. Following the recent emergence of the new SARS-CoV-2 ‘variant of concern’, Omicron (B.1.1.529), WHO has reported that interleukin 6 receptor blockers such as Actemra/RoActemra are expected to still be effective for managing patients with severe COVID-19.

Results from a prospective meta-analysis of almost 11,000 patients across 27 clinical trials found that treatment of hospitalised patients with severe or critical COVID-19, with IL-6 receptor blockers such as Actemra/RoActemra, were associated with improved mortality and reduced progression to invasive mechanical ventilation or death compared with usual care or placebo. These results were published by researchers from WHO in The Journal of the American Medical Association.