CHMP Recommends EU Approval of Actemra/RoActemra to Treat Patients with Severe COVID-19

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the marketing authorisation for Actemra/RoActemra (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. A final decision regarding the approval of Actemra/RoActemra is expected from the European Commission in the near future.

“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,” said Levi Garraway, M.D., Ph.D., 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.”

In August 2021, the EMA’s CHMP began an accelerated assessment of Actemra/RoActemra – this rapid analysis is reserved for medicines that may offer significant benefit to public health. The assessment reviewed results from four studies in over 5,500 patients with severe or critical 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 totality of this clinical evidence demonstrated that Actemra/RoActemra reduced the risk of death in patients with severe or critical COVID-19.

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. Roche is working closely with regulatory bodies and other partners around the world on the next steps to bring this medicine to as many people as possible.

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.

In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic.