WHO grants prequalification of Actemra/RoActemra for critical COVID-19 patients
Drug Approval

WHO grants prequalification of Actemra/RoActemra for critical COVID-19 patients

Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra

  • By IPP Bureau | February 20, 2022

Roche recently 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.2 Roche has established a comprehensive access approach to improve availability of both medicines around the world.

Actemra/RoActemra is approved for use in multiple territories including the European Union, Ecuador, Honduras, Japan, Myanmar, Peru, the United Kingdom and Ukraine, provisionally approved in Australia, and authorised for emergency use in Ghana and the United States for defined patients hospitalised with severe or critical COVID-19.

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