FDA approves Roche’s tocilizumab to treat COVID-19 in hospitalized adults

[Actemra image courtesy of Roche]

Roche (SIX:RO,ROG; OTCQX:RHHBY) has announced that it has received FDA approval for the intravenous (IV) monoclonal antibody Actemra (tocilizumab).

Tocilizumab, which targets the interleukin-6 receptor, first won FDA approval to treat rheumatoid arthritis in 2010. Since then, the monoclonal antibody has won a string of additional indications related to arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome.

Interleukin-6 can act as a pro-inflammatory cytokine. Researchers have found elevated levels of the interleukin in patients with severe COVID-19.

The most recent indication covers hospitalized adults receiving systemic corticosteroids who need supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

The monoclonal antibody is the first to win approval for patients with se…

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WHO prequalifies aIL-6R therapy for patients with severe or critical COVID-19 

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 p…

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