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Roche : CHMP Recommends EU Approval Of Actemra/RoActemra To Treat Severe COVID-19

Roche (RHHBY) said that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP has recommended extending the marketing authorisation for Actemra/RoActemra (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

The European Commission is expected to make a final decision regarding approval in the near future.

Actemra/RoActemra has been provisionally approved in Australia, authorised for emergency use in the United States and Ghana, and recommended by the World Health Organization or WHO for the treatment of COVID-19.

Roche said it is working closely with regulatory bodies and other partners around the world on the next steps to bring this medicine to as many people as possible.

Following the recent emergence of the new SARS-CoV-2 variant of concern, Omicron (B.1.1.529), WHO has reported that interleukin 6 receptor blockers, such as Actemra/RoActemra, are expected to still be effective for managing patients with severe COVID-19.

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