Business & Finance
Genentech's Actemra wins FDA's priority review for the treatment of COVID-19 in hospitalised adults
4 April 2022 -

Genentech reported on Monday the receipt of the US Food and Drug Administration's (FDA) priority review for Actemra intravenous (IV) for the treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

A decision on US FDA approval for the company's supplemental Biologics License Application (sBLA) for Actemra (tocilizumab) intravenous (IV) is expected in the second half of this year.

The sBLA for Actemra (tocilizumab) intravenous (IV) is based on results from the company's four randomized, controlled studies (EMPACTA, COVACTA, REMDACTA and RECOVERY) that evaluated Actemra for the treatment of COVID-19 in 5,500 hospitalized patients. Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. EMPACTA was the first global, Phase III study to focus on patients from underrepresented racial and ethnic groups.

Currently, Actemra is approved for use in 16 countries for defined patients hospitalised with severe or critical COVID-19. The WHO prequalified Actemra for patients with severe or critical COVID-19, supporting access to care in low- and middle-income countries. WHO reported that interleukin-6 receptor blockers, Actemra, are expected to still be effective for managing patients with severe COVID-19.

Both Genentech and Roche are monitoring the Actemra supply situation and seeing progress toward consistent, uninterrupted patient access to Actemra IV. The changing nature of the pandemic may impact availability of Actemra subcutaneous (SC) and IV formulations.

Genentech is a member of the Roche Group (SIX:RO) (OTCQX:RHHBY). a healthcare company.



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