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

  • WHO’s prequalification adds to several mechanisms already in place to improve access to Actemra/RoActemra for people with COVID-19 in low- and middle-income countries
  • Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra, as recommended in global treatment guidelines
  • Twelfth Roche medicine or test to be prequalified

Roche today 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.1 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. This includes:

Providing Actemra/RoActemra at cost to WHO and partners of the Access to COVID-19 Tools Accelerator (ACT-A) Initiative, to distribute to low- and middle-income countries in line with public health needs, thereby building on the significant portion of Actemra/RoActemra supply that Roche has provided to upper-middle- and lower-middle-income countries since the beginning of the pandemic.3
Working with ACT-A partners/UNICEF to donate Ronapreve, together with Regeneron, to support the most vulnerable communities in low-and middle-income countries in the event of future variants for which Ronapreve might have utility.3
Not asserting any patents against the use of Actemra/RoActemra in COVID-19 in low- and middle-income countries during the current pandemic (alongside Chugai), to provide legal certainty for biologic manufacturers who are ready and able to produce the medicine.3
Implementing an international differentiated pricing strategy specifically designed to address needs during this pandemic and improve affordability across upper-middle-, lower-middle- and low-income countries.3
Overcoming industry-wide supply challenges as the pandemic has evolved, including dedicating our largest manufacturing facility exclusively to producing COVID-19 medicines and working with partners to transfer technologies to maximise production.3

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.3 The Roche cobas® SARS-CoV-2 Test on the cobas® 6800/8800 Systems is also included in Roche’s Global Access Programme for low- and middle-income countries, reinforcing Roche’s continued commitment to further improve access to reliable and vital diagnostics at affordable prices, which is crucial to combat this global pandemic.3

About Actemra®/RoActemra® (tocilizumab) in COVID-19
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. It has also been recommended by the World Health Organization (WHO).

Multiple studies have evaluated the efficacy and safety of Actemra/RoActemra, including the Roche-led COVACTA, EMPACTA and REMDACTA trials, and the University of Oxford-led RECOVERY study. WHO has also reported that IL-6 receptor blockers, such as Actemra/RoActemra, are expected to still be effective against the SARS-CoV-2 variant of concern, Omicron (B.1.1.529).

Actemra/RoActemra is a first-in-class anti-interleukin-6 receptor (aIL-6R) therapy for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis and chimeric antigen receptor T-cell induced severe or life-threatening cytokine release syndrome, in addition to COVID-19. It is approved in more than 110 countries.

About Ronapreve™ (casirivimab and imdevimab)
Ronapreve (known as REGEN-COV™ in the United States [US] and invented by Regeneron) 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. It has also been conditionally recommended by the World Health Organization (WHO) for the treatment of patients with COVID-19.

About Roche’s response to the COVID-19 pandemic
As a leading healthcare company, we are doing all we can to support countries in their fight against COVID-19 and minimising its impact. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection, as well as providing digital support to healthcare systems. We also continue to identify, develop, and support therapies which can play a role in treating the disease.

About Roche
Founded in1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

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