Roche's 'Actemra' Approved as COVID-19 Treatment in Europe

[Asia Economy Reporter Kang Nahum] Roche's 'Actemra' (generic name tocilizumab) has been approved by the European Union Commission (EC) as a treatment for severe COVID-19 patients. In South Korea, JW Pharmaceutical holds the development and sales rights for Actemra.

According to foreign media on the 8th, the EC accepted the recommendation of the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on the 7th (local time) and approved Roche's Actemra as a treatment for severe COVID-19. Actemra is used for adult patients receiving systemic corticosteroid therapy who require oxygen supplementation or mechanical ventilation.

Actemra, a rheumatoid arthritis treatment, is an immunosuppressant that reduces inflammation by inhibiting the protein 'interleukin-6' (IL-6), which is involved in the inflammatory process of various diseases.

This approval follows the CHMP's recommendation after reviewing four studies involving more than 5,500 severe COVID-19 patients. Previously, the CHMP recommended approval after confirming that Actemra reduced the risk of death in studies involving hospitalized COVID-19 patients.

In key studies, patients treated with Actemra alongside standard corticosteroid therapy showed a 31% mortality rate within 28 days of treatment. In contrast, the group receiving only standard therapy had a 35% mortality rate. Additionally, the discharge rate within 28 days was 57% in the Actemra plus standard therapy group, compared to 50% in the standard therapy-only group.

Previously, Actemra received provisional approval as a COVID-19 treatment in Australia and emergency use authorization in the United States and Ghana. The World Health Organization (WHO) also recommended the use of arthritis treatments such as Actemra and Sanofi's Kevzara for treating severe COVID-19 patients.