Roche (SWX:ROG) has won World Health Organization (WHO) prequalification for Actemra/RoActemra.
Actemra/RoActemra is an anti-interleukin-6 receptor (aIL-6R) receptor antagonist with tocilizumab as an active substance.
The prequalification will assist in low- and middle-income countries in procuring the therapy for patients on systemic corticosteroids who require supplemental oxygen or mechanical ventilation.
Actemra/RoActemra is the twelfth medicine to win prequalification.
“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,” said Bill Anderson, CEO of Roche Pharmaceuticals, in a news release.
Roche will provide Actemra/RoActemra to WHO and partners at cost.
The company also said it would not assert its patent rights for the use of Actemra/RoActemra in COVID-19 in low- and middle-income countries for the course of the pandemic.
Tocilizumab was developed by Roche’s Genentech unit. It first won FDA approval in 2010 for rheumatoid arthritis, and has won several additional indications since. Tocilizumab won emergency use authorization as a COVID-19 therapy in 2021.