The World Health Organization (WHO) has issued a prequalification for Roche’s Actemra/RoActemra (tocilizumab). This means the treatment meets the WHO standards for quality, effectiveness and safety and can be used for adults who have severe or critical COVID-19 – those who are being treated with systemic corticosteroids and require additional oxygen or ventilation.
Since the start of the COVID-19 pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra, following global treatment guidelines.
Bill Anderson, chief executive officer of Roche Pharmaceuticals, said: “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.
“People from many low- and middle-income countries continue to feel the devastating impact of COVID-19 and care needs remain unprecedented,” he added.
Actemra/RoActemra and Ronapreve – also known as casirivimab and imdevimab, developed by Regeneron – were recommended in WHO’s Therapeutics and COVID-19 Living Guideline in 2021.
To help low- and middle-income countries gain access, Roche provides Actemra/RoActemra at cost price to WHO and partners involved in the Access to COVID-19 Tools Accelerator (ACT-A) Initiative.
Roche also works with ACT-A partners and UNICEF to donate Ronapreve – in collaboration with Regeneron – to protect the most vulnerable living in low-and middle-income countries against possible future coronavirus variants.
Actemra/RoActemra has been approved for use in the EU, the UK and other countries, and has been provisionally approved in Australia.
The treatment has also been authorised for emergency use in the US for patients hospitalised with cases of severe or critical COVID-19, and has been recommended by WHO.