Roche gets WHO prequalification for Tocilizumab to treat severe COVID-19
Basel: Roche has announced that Actemra/RoActemra (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification.
Prequalification is a confirmation by WHO that Actemra/RoActemra meets the WHO standards for quality, safety and efficacy for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. It helps procurers in low- and middle-income countries identify priority medicines to improve access to care and support better health.
"People from many low- and middle-income countries continue to feel the devastating impact of COVID-19, and care needs remain unprecedented," said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. "We've partnered with WHO and others throughout the last year to ensure that our COVID-19 medicines and tests can potentially reach more than 100 low- and middle-income countries, and WHO's prequalification of Actemra/RoActemra is just one of the paths taken together to achieve this. We will keep working tirelessly so that our COVID-19 care options reach as many people in need as possible."
Actemra/RoActemra and Ronapreve (casirivimab and imdevimab, known as REGEN-COV in the United States) were recommended in WHO's Therapeutics and COVID-19 Living Guideline last year. Roche has established a comprehensive access approach to improve availability of both medicines around the world.
In addition to the supply of its medicines, Roche has enabled more than 1.2 billion COVID-19 tests since the start of the pandemic, informing healthcare decisions around the world. The Roche cobas SARS-CoV-2 Test on the cobas 6800/8800 Systems is included in Roche's Global Access Programme for low- and middle-income countries.
Ronapreve is approved for use in the European Union, Japan, New Zealand and Switzerland, conditionally approved in Australia and the United Kingdom, and authorised for emergency or temporary pandemic use in additional territories such as Canada and the US. Ronapreve is available to COVID-19 patients in more than 50 countries, including upper-middle- and lower-middle-income countries.
The efficacy and safety of Ronapreve have been studied across multiple phase III clinical trials in non-hospitalised and hospitalised COVID-19 patients, and in the preventive setting.
Recent in vitro analyses and structural modelling have shown that Ronapreve has diminished potency versus the SARS-CoV-2 variant of concern, Omicron (B.1.1.529). Ronapreve has shown to retain its activity against all other main variants of concern, including Delta (B.1.617.2).
Ronapreve is being jointly developed by Roche and Regeneron. It is a combination of two monoclonal antibodies, casirivimab and imdevimab, and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
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