Introduction: People in many low- and middle-income countries continue to suffer the devastating effects of COVID-19, with unmet treatment needs. Roche continues to work hard to reach more patients with its COVID-19 treatments.
On February 11, 2022, Roche announced that the intravenous (IV) dose of Actemra®/RoActemra® (tocilizumab, tocilizumab) has received prequalification from the World Health Organization (WHO). Prequalification is WHO’s confirmation that tocilizumab meets WHO’s standards for quality, safety and effectiveness for the treatment of adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. It helps medicine purchasers in low- and middle-income countries identify priority medicines to improve access to care and support improved health outcomes.
In 2021, the WHO Treatment Approach and COVID-19 Lifestyle Guidelines recommend the use of tocilizumab and Ronapreve™ (casirivimab/imdevimab, ronaprevir, known as REGEN-COV® in the United States). Roche has established a comprehensive access approach to increase the global availability of both medicines. This includes:
Tocilizumab is provided at cost to WHO and partners in the Access to COVID-19 Tools Acceleration Initiative for distribution to low- and middle-income countries based on public health need. As a result, Roche has supplied large quantities of tocilizumab to upper-middle-income and lower-middle-income countries since the beginning of the pandemic.
In partnership with ACT-A Partners/United Nations Children's Fund (UNICEF), Regeneron is donating ronapril to support the most vulnerable communities in low- and middle-income countries as they respond to ronapril-treatable COVID-19 variants.
No patents are being asserted for the use of tocilizumab (against COVID-19) in low- and middle-income countries during the current pandemic, in order to provide legal certainty to biomanufacturers who are ready and capable of producing this medicine.
Execute an international differentiated pricing strategy designed to meet demand during the pandemic and improve affordability in upper-middle, lower-middle and low-income countries.
As the pandemic evolves, industry-wide supply challenges need to be overcome, including dedicating our largest manufacturing facilities to producing COVID-19 medicines and working with partners to transfer technology to maximize production.
In addition to delivering medicines, Roche has conducted more than 1.2 billion COVID-19 tests since the pandemic began, informing healthcare decisions around the world. The Roche cobas® SARS-CoV-2 virus test, performed on the cobas® 6800/8800 system, is also included in Roche’s global access program for low- and middle-income countries. Roche continues to work to make testing affordable for countries, which is critical to combating this global pandemic.
Actemra/RoActemra (tocilizumab) is a monoclonal antibody drug developed by Roche that targets the interleukin-6 receptor (IL-6 receptor). The drug is currently on the market in China for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sJIA). In June 2021, the FDA granted emergency use authorization (EUA) to tocilizumab for the treatment of COVID-19 hospitalized adult and pediatric patients (2 years and older) who are receiving systemic corticosteroids and require supplemental oxygen/non-invasive or invasive ventilation/extracorporeal membrane oxygenation (ECMO); in December 2021, tocilizumab was approved in Europe.
References:
https://www.roche.com/media/releases/med-cor-2022-02-11b.htm
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