EU Approves Roche's Actemra/RoActemra Against Severe Covid-19

By Mauro Orru

The European Union approved a potential medicine developed by Roche Holding AG to treat people with severe Covid-19.

The Swiss pharmaceutical major said Tuesday that the European Commission, the EU's executive arm, had extended the marketing authorisation for Actemra/RoActemra to include the treatment of Covid-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

"Actemra/RoActemra is the second Roche medicine to have received rapid European Commission approval in Covid-19 in recent weeks," said Levi Garraway, Roche's chief medical officer and head of global product development.

"The totality of evidence shows that Actemra/RoActemra can benefit those suffering with severe Covid-19," Mr. Garraway said.

The decision comes after the European Medicines Agency's Committee for Medicinal Products for Human Use reviewed results from four studies of the potential medicine in more than 5,500 patients with severe or critical Covid-19.

The World Health Organization has recommended Actemra/RoActemra for the treatment of Covid-19, expecting the medicine to be effective despite the emergence of the new Omicron variant.

The drug has also received provisional approval in Australia, and is authorized for emergency use in the U.S. and Ghana.

Write to Mauro Orru at [e-mail]; @MauroOrru94

(END) Dow Jones Newswires

December 07, 2021 04:36 ET (09:36 GMT)

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